Recall Z-2311-2021— Cell Marque Corporation
Class III · Ongoing
Class III FDA medical device recall by Cell Marque Corporation, initiated 2021-07-15. FDA's recall record names no specific 510(k) clearance for this event. Product: Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16. 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..
- Recalling firm
- Cell Marque Corporation
- Classification
- Class III
- Status
- Ongoing
- Initiated
- 2021-07-15
- Firm location
- Rocklin, CA, United States
Product description
Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.