Reported Aug 25, 2021 · Ongoing

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

Cell Marque Corporation

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cell Marque Corporation · 6600 Sierra College Blvd · Rocklin, CA · 95677-4306

Is this the product you have?

  • Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody
  • REF
    • 324M-15
    • 324M-16
Lot codes and dates
  • Item/Lot
    • 324M-15/0000116695
    • 324M-16/0000116696
Amount recalled
20

Where it was sold

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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:56 PM UTC

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