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Abbott BinaxNOW Covid test expiration


sambamama
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FYI:

 

For anyone buying these tests:  Abbott made a huge amount of these tests.  Originally they had a short expiration life.  They have now gotten approval to extend the life of these tests up to a year-some are only 6 or 9 months however.  BE AWARE if you buy a number of them that you will get tests expiring in January or February-and the website and your test won't make that clear.  The top date is the original expiration date, the later date the new expiration date.  There are batches of these tests-that number will be on there as well-195-000, 195-100, 195-200.  To my knowledge (I am not positive about this), they are not making new ones, or if so, they aren't selling those ones.  Buried in their website is that the tests are non-returnable, and that any lawsuit must go to arbitration.  As they don't have any documentation on the website about the expiration of the 195-100 tests, or that the tests they are selling you don't expire in a year, I am not sure if this holds up legally.  I think it is potentially deceptive, and any contractual claims can be barred as claims of adhesion.  Certainly the easiest way around this is just to buy the amount you need immediately.  Also, as an FYI, when I called the company, I had a 45 minute for a representative, and she was quite rude and refused to give me tests with longer expiration dates (perhaps because they don't have any.)  She also refused to let me speak to a supervisor.  The tests I bought list an original expiration date of 10/8/21 (my cruise sails 10/23) and the new date is 2/8/22.  I bought six for $175 intending to use them over the next year.  I checked on the website and founds in the FAQs they had a 1 year expiration period-otherwise, I would have bought two.  

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Hi Stephanie,

This is good information about the expiration date. The problem is that it is difficult here in Seattle to find a rapid test--a test quick enough to take 72 hours before reaching Europe from the west coast. CVS and Walgreens are not offering rapid tests everywhere and Walgreens is keeping the rapid tests for those with symptoms.

 

Abbott Binax NOW kits  Home Test vs Self Test

We were just talking about Abbott BinaxNOW Covid-19 Ag Home Tests versus Abbott BinaxNOW Covid-19  Antigen Self Test on a another roll call. Some people are purchasing tests that are not monitored, and thus not able to be certified for boarding ships or entering the US or other countries.

 

The Antigen Self Test, sold by CVS, Walgreens, and Walmart is less expensive, since it does not include the services of a monitor for verification. It is to reassure yourself, but I do not believe the “self-test” will be accepted by cruise lines or Italy or the US for entry. 

 

BinaxNOW offers Abbott BinaxNOW Covid-19 Ag Home Tests (six for $110 + shipping). The other option is six of the Home Tests from eMed.com for $165 + shipping. 

 

The Abbott BinaxNOW Covid-19 Ag Home Tests have the same test as the Antigen Self Test. But, the Ag Home test  kit bundles the Antigen Self Test + the Novice app. The Navica app is the monitoring feature (basically a zoom call), which is what makes the BinaxNOW test acceptable to the CDC and other governments. (Any self-test must be monitored in order to make it certified.)

 

Here is more information:

https://www.globalpointofcare.abbott/en/product-details/navica-binaxnow-covid-19-us.html

https://www.abbott.com/corpnewsroom/diagnostics-testing/abbotts-new-NAVICA-app-what-you-need-to-know.html

 

Diana

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9 hours ago, sambamama said:

BE AWARE if you buy a number of them that you will get tests expiring in January or February-and the website and your test won't make that clear.  The top date is the original expiration date, the later date the new expiration date.  

 

It is definitely frustrating that the test kits shipping now have only a few months left before they expire.  Perhaps it helps to understand why, even though, as consumers, it's quite frustrating.  As was reported in the NY Times, the market for test kits took a nosedive in the late spring after vaccines became widely available and the number of Covid cases declined steeply, and Abbott reacted by scaling down production.   Unfortunately, months later, the Delta variant cause the surge in cases in which we are now caught up, and Abbott has had to ramp up operations.  In the meantime, it is clearly shipping the kits it still has on hand.  

 

The test kits originally had a shelf life of about 9 months, but the FDA extended that to 12 months based on data showing longer shelf-life stability.  The FDA's letter, linked below, is on eMed.com's web site.  (eMed are the folks who proctor the tests, and one of the on-line sellers of the tests.  The other is Optum.)

 

https://www.emed.com/hubfs/EUA-abbott-binaxNOW-Rev-2021-04-06.pdf?hsLang=en  

 

The label on the test kit box shows the original expiration date, but it does not show the actual, extended date.  For that, one needs to consult one of the Abbott letters that can be found on line) (do a Google search for your Lot number, e.g. BinaxNow LOT xxx) such as these linked below, that contain lists of the lot numbers and their actual expiration dates:

 

https://coronavirus.ohio.gov/static/binax-now/COVID-19-Ag-Card-Product-Expiry-Update.pdf

 

https://www.emed.com/hubfs/Case 01269955-COL-03030 BinaxNOW™ COVID-19 Ag Home Test Product Expiry Update - Customer Letter EN - US.pdf?hsLang=en

 

10 hours ago, sambamama said:

There are batches of these tests-that number will be on there as well-195-000, 195-100, 195-200. ...  Buried in their website is that the tests are non-returnable, and that any lawsuit must go to arbitration.  As they don't have any documentation on the website about the expiration of the 195-100 tests . . .

 

The  number 195-100 is not a lot number.  It is Abbott's catalogue/reference number.  It's not the number linked to an expiration date.   Here's a photo of a test kit box.  You can see 195-100 in two places (circled in yellow and at the red arrow): it's the Reference number.   The LOT number is plainly identified by the word "LOT" -- see the lavender arrow.  It is the LOT number that is tied to an expiration date.  In this case, the original expiration date was Oct. 3, 2021 -- the date next to the hourglass icon, the symbol of the expiration date.  (The lot was manufactured on Feb. 2, 2021, the other date on the label.)   Looking up Lot number 142400 on the second Abbott letter linked above, we find that the extended expiration date is Jan. 3, 2022. 

 

enhance

 

The Refund policy on the eMed web site says that:

"We are unable to provide a refund or a replacement kit due to expiration. The FDA granted an additional 3-month shelf life to the printed expiration date on the BinaxNOW™ COVID-19 Ag Card Home Test kits. Current test kit expiration dates may be as early as December 2021. Please review the letter issued by the FDA here for more information: https://eMed.com/FDA."

https://www.emed.com/cancellation-policy?hsLang=en

 

I hope this additional information is helpful.

 

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We were also unfortunate enough to buy a six pack, that will only be good for our November cruise.  We will have to buy more for our February cruise.  At least we have it, too stressed out about it all.  Still looking forward to the cruise, IF we can get our booster, lol (I wish I could laugh, but we are six months past our second Moderna).  We are bound and determined to go, will be first plane flights and cruise in two years.   So yup, not happy about the expiration dates.  Will stress about the second cruise later.

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I certainly understand why.  I get that.  And I apologize for referring to the number as a lot number and not as a reference number.  And actually, there is no letter for the reference number 195-100 (on the website or otherwise-I googled!) I am not asking them to stop selling the kits it has.  I am just asking them to sell the kits they have IN AN INFORMED MANNER SO AS TO NOT RIP OFF CONSUMERS!  This is what they are doing, and this is what is totally reprehensible about their company's behavior.  We shouldn't have to spend hours researching a medical product in order to buy it.  This is why they are marketing it in batches of six, and why they forbid you to sell it or give it to anyone else.  I majored in biology and minored in chemistry and understand all this.  But I will do my part to stand up to Emed and I will sue them for a consumer protection action as they are engaging in deceptive behavior.

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And yes, I was unclear, I am talking about the Abbott BinaxNOW Covid tests that come complete with a test using the Navica app, so they are acceptable for travel by air or to a cruise line.  I posted this after waiting 45 minutes to talk to an Emed rep who was rude and snarky to me, so I was pretty hot under the collar when I wrote the first post. 

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On 9/20/2021 at 9:27 AM, sprinkles said:

We were also unfortunate enough to buy a six pack, that will only be good for our November cruise.  We will have to buy more for our February cruise.  At least we have it, too stressed out about it all.  Still looking forward to the cruise, IF we can get our booster, lol (I wish I could laugh, but we are six months past our second Moderna).  We are bound and determined to go, will be first plane flights and cruise in two years.   So yup, not happy about the expiration dates.  Will stress about the second cruise later.

Sprinkles,

if your extra tests aren’t already registered to you and can be used by anyone, I am going to need 3 for a cruise in early December. I also have a cruise in early February and was going to buy a 6 pack but don’t want the second 3  to expire before I need them at the beginning of February.

If you think I’d be able to use your extra ones, I’m willing to buy them from you so you don’t end up with expired tests.

 

 

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There are a couple of threads about this on the Carnival board.  People are buying them for cruises several months out and then freaking out because they will probably expire before then, even with the extended expiration date.  But they won't wait to purchase them in case they can't get them at all, which only adds to the expected shortage.

 

I have a cruise in mid-November and one in December.  Although I believe and I can get tested locally within the time frame (if it's still 48 hours), I'm thinking of purchasing these.

 

Don't want to wait too long but don't want to purchase too early.  But also hate the idea that I'd buy them and not need them, preventing someone else from getting their hands on them.

 

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I ordered 6 tests from eMed yesterday.  The tests were delivered today via FedEx.  The expiration date on the tests is 9/18/21, a couple of days before I ordered.  Our cruise begins December 1, 2021.  I printed the April 6, 2021 FDA letter that states that the updated shelf life date of the card is 12 months and plan to carry it with me (although I can't imagine the test proctor requesting to see it).  We plan to take the tests one week before we travel to FL and 2 days before the cruise (we will be in FL more than 2 days before the cruise).  Initially we thought we would participate in the testing at the airport, but that was when the testing requirement was 3 days prior and would have been upon our arrival at FLL.

BaltimoreCruise

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2 hours ago, sambamama said:

I certainly understand why.  I get that.  And I apologize for referring to the number as a lot number and not as a reference number.  And actually, there is no letter for the reference number 195-100 (on the website or otherwise-I googled!) I am not asking them to stop selling the kits it has.  I am just asking them to sell the kits they have IN AN INFORMED MANNER SO AS TO NOT RIP OFF CONSUMERS!  This is what they are doing, and this is what is totally reprehensible about their company's behavior.  We shouldn't have to spend hours researching a medical product in order to buy it.  This is why they are marketing it in batches of six, and why they forbid you to sell it or give it to anyone else.  I majored in biology and minored in chemistry and understand all this.  But I will do my part to stand up to Emed and I will sue them for a consumer protection action as they are engaging in deceptive behavior.

I agree 100 %. It's taken me longer to research the expiration dates on the tests than it has to plan for my entire cruise. By the way, my cruise leaves on Jan 2, 2022 and my tests expire on 12/28/2021... so close... but not close enough. I just got off the phone with a rep from the company, and after I gave my explanation, I was put on hold for a supervisor. Word came back to me that I would be offered a refund but they could not send me a test with a longer expiration date. I asked when I would receive the refund and was told "someone will be contacting me". I'm not holding by breath on getting a call-back.

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Baltimore Cruise, your tests may not be good. That letter means the tests are good for up to a year, BUT your expiration date is September. You need to look up your reference number and hope it matches to something. Do you have a lower expiration date? Do you have a reference date? It should be 195-000 or 195-100 or something similar. Since your cruise is in December, you are probably good. But that letter won't help you-you have to call in to the Navica app and hope Emed says the test is valid. I urge everyone to file consumer protection lawsuits as Emed is trying to rip people off. They don't publish any warning about the expiration date anywhere on their website. I myself wrote to the NY Times today and the Elliott consumer protection website earlier. If anyone needs help with a refund, go to the Elliott site-you can get help there or look on your state's consumer protection section at your attorney General. 

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56 minutes ago, sambamama said:

Do you have a lower expiration date? Do you have a reference date? It should be 195-000 or 195-100 or something similar.

 

As I explained in comment 4 above, the Reference (REF) number on the label (195-100) is merely an Abbott catalogue or part number, it has nothing to do with the expiration date. That date is tied to the LOT number, also on the label. See the photo in comment 4 above.  Once you have the LOT number, you can look up the new expiration date in one of the Abbott letters posted on line; I’ve linked two of them in comment 4. It’s not the best system, but the information is out there. 

1 hour ago, sambamama said:

I urge everyone to file consumer protection lawsuits as Emed is trying to rip people off. They don't publish any warning about the expiration date anywhere on their website. 
 


While I think eMed could do a better job on its website of clearly warning people about the expiration date, it’s not correct to say there’s no warning “ anywhere on their website.”  As I noted in comment 4, the warning, which I quoted, is stated in their Refund and Cancellation policy.  It would be better included along with information about the kits themselves, but it’s not correct to say it’s nowhere on the site. 

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Sorry for what might be a stupid question, but how do you set an appointment?  Are you even able to schedule an appointment in advance or do you just log in to emed/navica when you're ready to test?  

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57 minutes ago, Aquahound said:

Sorry for what might be a stupid question, but how do you set an appointment?  Are you even able to schedule an appointment in advance or do you just log in to emed/navica when you're ready to test?  

You just log in when ready to test. No appointments at all

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23 hours ago, BaltimoreCruise said:

I ordered 6 tests from eMed yesterday.  The tests were delivered today via FedEx.  The expiration date on the tests is 9/18/21, a couple of days before I ordered.  Our cruise begins December 1, 2021. 

The extension of the expiry dates by three months in existing kits (per FDA approval letter) means your new expiration date is December 18, 2021.

 

The kits will still be good for your 12/1/21 cruise.

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Emed just refunded all my money for my tests.  I will say I saw data on the Emed site that is now longer there showing that not all tests were extended for 12 months. As to whether Emed is still selling those referenced tests, I can't say.  I can say that on Saturday there were two different data sheets showing reference tests 195-000 with different manufacture dates that expired in less than twelve months.  Those sheets were removed and the only thing left now is just the letter saying the tests are good for twelve months. I am not sure if there are any currently manufactured tests even available.  

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BIG FYI FOLLOW UP:  I got an email from Emed regarding both the refund of my purchase of the kits AND the expiration dates.  My tests listed that they expired October 5, 2021.  They were manufactured February 8, 2021.  The Emed employee who wrote me informed me my tests expire three months later-which puts them expiring January 5, 2022. THAT DATE IS NOT 12 MONTHS LATER!  So this means some expire in 12 months, and some expire in less than 12 months.  

 

Turtles6, you are correct that Emed does list those policies on their website.  But they are listed in places where most people don't click.  People click on FAQs-and not usually the fine print of the website. They don't advise you the tests they sell you will, in all likelihood, expire within 3-5 months AND the Abbott letters about the expiration dates that were on the website are no longer on the website-I checked today.  Based on what I am seeing right now, I would not order from Abbott again.  Or, I would not order 6 kits, and I would order right before I needed them.  And Emed is only selling them in 6 packs.  They need to change their ordering policies to guarantee you get a test that is valid for when you are going to travel.  

 

I did a fair bit of research when I drafted my consumer protection claim letter (that won't be filed as my claim is now void.)  There is a NY Times article talking all about how Emed manufactured millions of tests and then destroyed them  (over 8 million) when the bottom fell out of the market.  Now that the market has risen again, they are selling them, but they aren't making new ones-they are selling the old ones since they got the expiration dates extended.  Check the NY Times article written August 20, 2021.  I have no issue with them selling a good product.  But I do have an issue with them implying these kits last for 12 months and selling them in lots of six and then sending you ones that may expire before your travel date.  You are better off trying to get a free test from Quest for your HAL cruise.  

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It is going to be interesting to see if they will start manufacturing again or get another extension. My tests are good through early Jan 2022 so I will be covered for my Nov cruise. Will need to figure something else out for my March sailing, but that is such a long way off particularly in COVID time who knows what will be required by then.

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6 hours ago, zgscl said:

It is going to be interesting to see if they will start manufacturing again or get another extension.

 

If you do a Google search, I think you'll find that they began ramping up again after the surge caused by Delta.   Also, the extension of the expiration dates on their test kits was given by the FDA not because of product shortage issues (in fact, the extension was granted back in April), but because the FDA was satisfied that the shelf life was several months longer than the original expiration dates.  Here's the FDA's letter, which is on the eMed web site:

 

https://www.emed.com/hubfs/EUA-abbott-binaxNOW-Rev-2021-04-06.pdf?hsLang=en

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On 9/21/2021 at 11:05 AM, cruisin'mama said:

Sprinkles,

if your extra tests aren’t already registered to you and can be used by anyone, I am going to need 3 for a cruise in early December. I also have a cruise in early February and was going to buy a 6 pack but don’t want the second 3  to expire before I need them at the beginning of February.

If you think I’d be able to use your extra ones, I’m willing to buy them from you so you don’t end up with expired tests.

 

 

I see you are in Riverside.  I'm in Corona so I can just drop them off on a weekend.  Happy to help a fellow cruiser.  I have the 6 pack and can give you 3 of mine, no charge.  Mine expires 1/5/22.  

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My issue is not with the product (which I think is a good one), or when they started ramping up-but simply how they are marketing this.  I find it unconscionable to market a product for travel and sell it non-refundable without people knowing what date their kits expire, and mailing them kits with such a short expiration date. If they publish the date when the kits you are buying expire, you are not buying a pig in a poke. Otherwise,  its like just buying a cruise that you have no idea what line you are buying, how long it is, and where it goes, and what cabin you are getting, or even if  you are free to sail when the cruise is sailing. If you were buying meat in a store, you look at the expiration date.  If it is close to expiring, the price goes way down.  If it expires, they take it off the market.  When Abbott's tests came close to expiring, they had the FDA review the expiration date.  And yet on my kits, there is no true expiration date.  The date based on the letter was obviously not accurate as why would Abbott write me and tell me the date is January 5, 2022 and not February 8, 2022?

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1 hour ago, psxer989 said:

I see you are in Riverside.  I'm in Corona so I can just drop them off on a weekend.  Happy to help a fellow cruiser.  I have the 6 pack and can give you 3 of mine, no charge.  Mine expires 1/5/22.  

I’m more than willing to come get them from you so you don’t have to go out of your way! And I’m definitely willing to pay for them!

You can email me @.  Takemeonacruise(at)Verizon.net

and thank you!!

Cathy

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1 hour ago, sambamama said:

My issue is not with the product (which I think is a good one), or when they started ramping up-but simply how they are marketing this.  I find it unconscionable to market a product for travel and sell it non-refundable without people knowing what date their kits expire, and mailing them kits with such a short expiration date. If they publish the date when the kits you are buying expire, you are not buying a pig in a poke. Otherwise,  its like just buying a cruise that you have no idea what line you are buying, how long it is, and where it goes, and what cabin you are getting, or even if  you are free to sail when the cruise is sailing. If you were buying meat in a store, you look at the expiration date.  If it is close to expiring, the price goes way down.  If it expires, they take it off the market.  When Abbott's tests came close to expiring, they had the FDA review the expiration date.  And yet on my kits, there is no true expiration date.  The date based on the letter was obviously not accurate as why would Abbott write me and tell me the date is January 5, 2022 and not February 8, 2022?

How often does this have to be explained (hopefully this explanation will not be deleted again as previous ones were).

 

The expiration date is based upon the stability data available at the time of the submission of a marketing application to the FDA.

 

When the test kits were first approved under an EUA, the expiration date was set for nine months after the sterilization date because that is the data that was available to support that period of time.

 

As  the kits that remained available for stability testing passed that point in time, enough data was available to support a request to extend the shelf life to twelve months.

 

FDA approved a twelve month shelf life . Kits packaged and sterilized after the FDA approval date for a twelve month expiration date will bear the twelve month expiration date.

 

Kits already out for distribution and stamped with the original nine month expiration had an additional three months added onto the original dates.

 

No, the packages were not recalled and relabeled with the new expiration dates.

 

Abbott and the test distributers instead readily supplied lists showing the old dates and new extended dates.

 

That is also why there are statements on sites stating the expiration dates can be UP TO twelve months from the date of purchase. This allows from the standard inventory control procedure where the oldest product is shipped first, but still within the expiration date when used as intended.

 

When the kit was first manufactured and distributed, it was intended as a at home test kit for those who needed to know if they had Covid 19. The kits were distributed two to a pack as a second test was provided to give a back up test for three days after the first test (depending on first test results) or as a test within two -three weeks to see if a positive patient was now negative.

 

The test was always intended to be purchased and used immediately (think home pregnancy test kit) and was never intended to be bought and hoarded for some distant date of use.

The kit is still not intended to be bought and hoarded for future use. The test reagent in the kit is sensitive to storage conditions (temperature and humidity). That is why the kits are shipped in a timely fashion and why buyers of the kits are warned to make sure that someone is available to receive the shipment.

 

The fact that people are now using the kits as a screening tool for travel does not changes the fact that kits should be purchased and used in a timely fashion.

 

There is no intent in selling a "pig in a poke."

 

Buy and use the kits as intended and there is no problem with the expiration dates.

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1 hour ago, Homosassa said:

When Abbott's tests came close to expiring, they had the FDA review the expiration date. 

 

That's just not true.  As you can see from the FDA letter that has been linked in this thread above and that is also linked on the eMed web site, the FDA granted Abbott's request for an extension of the expiration date way back on April 6, 2021, long before test kits were expiring.  (The earliest original expiration dates in the letters that Abbott then sent to customers in May to notify them of the extended expiration dates were not until September 2021.) 

 

https://vase.vdh.virginia.gov/vacapps/f?p=545:1

 

I realize you are unhappy with the eMed web site, and as I've said before, they could do a much better job on their site, but it doesn't help to state incorrect information (including the fact that eMed's web site says nothing at all about the expiration dates of what they are shipping, which you claimed in an earlier comment.  No need to re-hash that again). 

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