FDA Device recall Z-2311-2021
Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
- FDA Device
- Class III
- ongoing
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class III recall of Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16 by Cell Marque, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2311-2021 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2021-07-15 |
| Published | 2021-08-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cell Marque |
| Distribution | US |
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.
Identifiers
| code_info | Item/Lot: 324M-15/0000116695, 324M-16/0000116696 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2311-2021%22
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