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Recall Observatory FDA recall evidence

Device product

Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16

Z-2311-2021

July 15, 2021

Class III

Product summary

Firm
Cell Marque Corporation
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

    reason.no_named_rule · v1.0.0

    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.