FDAJuly 15, 2021device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

cell marquecell

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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