Cell Marque Antibodies — Class III medical device recall Z-2311-2021
Ongoing recall by Cell Marque Corporation, reported 2021-08-25, distributed nationwide. Mouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31
| Recall number | Z-2311-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cell Marque Corporation, Rocklin, CA, United States |
| Recall initiated | 2021-07-15 |
| Classified | 2021-08-18 |
| Reported by FDA | 2021-08-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BR, CA, KR, MX, TH |
| Quantity | 20 |
| Reason classes | labeling |
| Lot numbers | 324M-15/0000116695, 324M-16/0000116696 |
| Model numbers | 324M-15, 324M-16 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2311-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.