Device product
Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
Z-2311-2021
Product summary
- Event
- Event 88287
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 20
- Official record key
device-enforcement:Z-2311-2021
Official wording
Reason: Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. If used beyond expiry, the material performance is likely to decrease and may be observed as weak or no staining, and there is a potential risk that a false negative result could be recorded and may lead to delay of diagnosis due to retest.
Code information: Item/Lot: 324M-15/0000116695, 324M-16/0000116696
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of OR, DC, NJ, CA and the countries of Canada, Mexico, South Korea, Brazil, Thailand, Argentina.
Derived failure modes
-
Unknown
Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. If used beyond expiry, the material performance is likely to decrease and may be observed as weak or no staining, and there is a potential risk that a false negative result could be recorded and may lead to delay of diagnosis due to retest.