The Recall Desk
HighFDA (Devices)·Z-2311-2021·Announced 2021-08-25

Cell Marque Antibody Reagents Recalled for Incorrect Expiry Date Labeling

Cell Marque antibody reagents used in pathology are recalled for labeling an incorrect expiry date (December 31, 2023 instead of December 31, 2022). Using expired reagent may result in weak or absent staining and false negative test results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a Class III medical device recall involving a diagnostic reagent with mislabeled expiry dating. While no illnesses or injuries have been reported, there is a clear risk-of-harm: using expired reagent produces false negative test results, delaying diagnosis. Per the severity rubric, risk-of-harm products where injury has not been reported score as High (Score 3).

Plain-English summary

Cell Marque Corporation is recalling certain batches of Cell Marque Antibodies PSA (ER-PR8) Mouse Monoclonal Antibody used in pathology laboratories. The recalled batches are item/lot numbers 324M-15/0000116695 and 324M-16/0000116696.

The reagents are labeled with an incorrect expiry date of December 31, 2023. The correct expiry date is December 31, 2022. Because the labeling shows a later expiry date than the actual shelf-life, laboratories may continue using the reagent beyond when it should be discarded.

If used beyond the correct expiry date, the antibody performance is likely to degrade. Users may observe weak staining or an absence of staining in test samples. The risk is that a false negative result could be recorded, meaning a positive case appears negative, potentially delaying diagnosis for patients whose test results inform clinical decision-making.

The recalled products were distributed worldwide, including to laboratories in the United States (Oregon, District of Columbia, New Jersey, and California) and internationally to Canada, Mexico, South Korea, Brazil, Thailand, and Argentina.

The recalled product

Product
Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
Manufacturer
Cell Marque Corporation
Category
Medical Device — Diagnostic Reagent / Antibody
Hazard
  • expiry-mislabeling
  • false-negative
  • diagnostic-delay

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Item/Lot: 324M-15/0000116695
  • 324M-16/0000116696

Distribution

Distributed nationwide across the United States.

Related recalls

Same category