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

Recall date

July 15, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2311-2021

FDA classification

Class III

Brand / firm

Cell Marque Corporation

Sold / distributed

Worldwide distribution - US Nationwide distribution in the states of OR, DC, NJ, CA and the countries of Canada, Mexico, South Korea, Brazil, Thailand, Argentina.

Why it was recalled

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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