[Histonet] [External] Expiration date after opeing a reagent

[Rachel Gonzalez]

Hi

I agree the inspector is wrong.

I work in the manufacture of pathology reagents such as secondary polymers, diluents, buffers, antibodies, IF conjugates. We constantly test in real time to make sure that the product is as good on its expiration date as it is on day one. We are mostly for RUO,  I am sure that the larger companies such as Ventana Dako and Leica are doing the same. 

To be fair to the inspector maybe he is confusing antibodies that should be kept at -20C and are stored at 4C. Those antibodies will have a shorter half-life. We state this on our inserts with these antibodies.  

Rachel
-----Original Message-----
From: Thomas Podawiltz via Histonet <histonet at lists.utsouthwestern.edu> 
Sent: Friday, July 21, 2023 5:30 PM
To: Bitting, Angela K. <akbitting at geisinger.edu>; Paula <plucas at biopath.org>; histonet at lists.utsouthwestern.edu
Subject: Re: [Histonet] [External] Expiration date after opeing a reagent

I think that inspector has their head up their……….


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On Friday, July 21, 2023, 4:45 PM, Bitting, Angela K. via Histonet <histonet at lists.utsouthwestern.edu> wrote:

This sounds absurd to me.

-----Original Message-----
From: Paula via Histonet <histonet at lists.utsouthwestern.edu>
Sent: Friday, July 21, 2023 4:09 PM
To: histonet at lists.utsouthwestern.edu
Subject: [External] [Histonet] Expiration date after opeing a reagent

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Hello,



We just got CLIA inspected and had no deficiencies. The inspector did say he wants to see us write down on any reagent containers when it was opened, and write down the new expiration date.



The containers have the expiration date on them from the manufacturer, but the inspector said when the container is opened, the expiration will change and we need to write the date on the container under the opened date.



I've never heard of this requirement and I would like to ask if you have.
He said if the vendor does not give us any written documentation of when a reagent would expire after it's opened, then we should seek an alternate vendor who can.



Any comments, etc. are greatly appreciated.



Paula Lucas

Bio-Path Medical Group



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