Cell Marque Corporation Recall 88287
Description: Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16
Cell Marque Corporation Recall 88287 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2311-2021 |
| Event ID | 88287 |
| Event Description | Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16 |
| Product Type | Devices |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of OR, DC, NJ, CA and the countries of Canada, Mexico, South Korea, Brazil, Thailand, Argentina. |
| Quantity | 20 |
| Recall 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. |
| Device Classification | 20210825 |
| Device Code Info | Item/Lot: 324M-15/0000116695, 324M-16/0000116696 |
| Center Classification Date | 20210818 |
| Recall Initiation Date | 20210715 |
| Recalling Firm | Cell Marque Corporation |
| Initial Notification | Letter |
| Similar To |