BInaxNOW expiration dates

[WBHB]

Adding a separate topic as I didn’t quickly see where this had been discussed.  
 

I ordered 4 BinaxNOW test kits last week for a cruise later this month.   Upon delivery this week, I noticed that the batch that was shipped by Optum,  Carnival’s recommended vendor partner, had a manufacturing date of Jan 25, 2021, and an expiration date of Sept 21,2021.   
 

I called Optum and asked about shipping expired test kits in an effort to get them to resend me kits that had not expired.   They said that they did not have adequate supply to replace them, but they provided me with a letter from the FDA which extends the valid shelf life to 1 year from date of manufacture.  
 

Maybe this is a non issue, and I have this exemption letter now, but I’m nervous that someone will question my expiration dates on the test kits, deny our testing, and tell me that we need to purchase new kits before our cruise.  
 

I’m wondering if anyone else has noticed this issue.   EUA-abbott-binaxNOW-Rev-2021-04-06 (1).pdf

[groundloop]

I might be wrong but it seems that test kit expiration date is only of concern to e-med, and that once you do your test and they send your email you're good to go.  

 

I just now received the test kits I ordered a few days ago and they show a manufacture date of January 25, 2021, an expiration date of Sept. 21, 2021, and come with a notice that the FDA has granted a 3 month extension to all lots (see www.eMed.com/FDA).

[Homosassa]

22 minutes ago, WBHB said:

Adding a separate topic as I didn’t quickly see where this had been discussed.  
 

I ordered 4 BinaxNOW test kits last week for a cruise later this month.   Upon delivery this week, I noticed that the batch that was shipped by Optum,  Carnival’s recommended vendor partner, had a manufacturing date of Jan 25, 2021, and an expiration date of Sept 21,2021.   
 

EUA-abbott-binaxNOW-Rev-2021-04-06 (1).pdf

This issue has been beat to death in multiple threads on  the multiple cruise line forums.

 

Tour test kit expiry date was extended to December 21, 2021.

[Saint Greg]

It's the same batch I've got. Your sleeve over the box should mention the 3 month extension and have a QR code that takes you to the letter.

[nascartim]

1 hour ago, WBHB said:

Adding a separate topic as I didn’t quickly see where this had been discussed.  
 

I ordered 4 BinaxNOW test kits last week for a cruise later this month.   Upon delivery this week, I noticed that the batch that was shipped by Optum,  Carnival’s recommended vendor partner, had a manufacturing date of Jan 25, 2021, and an expiration date of Sept 21,2021.   
 

I called Optum and asked about shipping expired test kits in an effort to get them to resend me kits that had not expired.   They said that they did not have adequate supply to replace them, but they provided me with a letter from the FDA which extends the valid shelf life to 1 year from date of manufacture.  
 

Maybe this is a non issue, and I have this exemption letter now, but I’m nervous that someone will question my expiration dates on the test kits, deny our testing, and tell me that we need to purchase new kits before our cruise.  
 

I’m wondering if anyone else has noticed this issue.   EUA-abbott-binaxNOW-Rev-2021-04-06 (1).pdf

Well, I'm glad you brought this to our attention. I had heard about the 3 month extension, but this changes everything. 1 year makes a huge difference. I now have more time to use mine for another cruise. Thank You.

Edited October 15, 2021 by nascartim

[WBHB]

Groundloop, Greg, and Tim, thanks for your constructive comments and feedback.
 

 The sleeve on my test kits did not have any updated expiration dates, nor was there any other notification in the package.     

 

In any event, I have the FDA letter now in hand in case any issues arise, instead of arguing that some obscure guy on the Internet said the subject was beaten to death on multiple threads on multiple  boards.  
 

And yes, this letter would suggest that the expiration date could be beyond December 21.  
 

Enjoy your cruises and stay safe!   

[Saint Greg]

2 hours ago, WBHB said:

Groundloop, Greg, and Tim, thanks for your constructive comments and feedback.
 

 The sleeve on my test kits did not have any updated expiration dates, nor was there any other notification in the package.     

 

In any event, I have the FDA letter now in hand in case any issues arise, instead of arguing that some obscure guy on the Internet said the subject was beaten to death on multiple threads on multiple  boards.  
 

And yes, this letter would suggest that the expiration date could be beyond December 21.  
 

Enjoy your cruises and stay safe!   

you didn’t have this?

 

 

[gtalum]

The FDA has allowed the manufacturer to extend expiry dates by three months, so all the ones showing September 21 are still good until December 21.

[Sillyjilly]

4 hours ago, Saint Greg said:

you didn’t have this?

 

 

Mine just came in an envelope with none of the labeling.

[Homosassa]

17 hours ago, nascartim said:

Well, I'm glad you brought this to our attention. I had heard about the 3 month extension, but this changes everything. 1 year makes a huge difference. I now have more time to use mine for another cruise. Thank You.

No. You are misinterpreting the conditions of the FDA approval of the extension of the expiry date to twelve months. 

 

Only those test kits manufactured after the date of the FDA approval letter will be labeled with a twelve month expiry date.

 

Kits manufactured prior to the FDA approval have had their expiry date extended by three months.

 

 

[K&RCurt]

3 hours ago, Homosassa said:

No. You are misinterpreting the conditions of the FDA approval of the extension of the expiry date to twelve months. 

 

Only those test kits manufactured after the date of the FDA approval letter will be labeled with a twelve month expiry date.

 

Kits manufactured prior to the FDA approval have had their expiry date extended by three months.

 

 

The entire production of the current BiNax tests were done in one run.  They ALL expired in October originally, given a 9 month lifetime.  They were ALL extended by 3 months, resulting in a 12 month self life.  "By 3 month" and " 12 months" mean the same thing.