Device recall
Z-2311-2021: Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15…
FDA device recall · Class III · Cell Marque Corporation
Key facts
| Recall number (Z-number) | Z-2311-2021 |
|---|---|
| Recall event | 88287 |
| Product | Cell Marque Antibodies, PSA (ER-PR8) Mouse Monoclonal Antibody, REF: 324M-15, 324M-16 |
| Product code | NJT |
| Recalling firm | Cell Marque Corporation |
| Recall class | Class III |
| Status | Open, Classified |
| FEI number | 3000718726 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database