Device recall
Z-2038-2016: SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15…
FDA device recall · Class II · Cell Marque Corporation
Key facts
| Recall number (Z-number) | Z-2038-2016 |
|---|---|
| Recall event | 74179 |
| Product | SIOOA I (EP I84) Rabbit Monoclonal Antibody; Catalogue numbers 408R-14, 408R-15, and 408R-16; Part number: 470361. Intended for identifying by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin embedded tissue sections using IHC test methods. |
| Product code | NJT |
| Recalling firm | Cell Marque Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 23, 2016 |
| 510(k) numbers | K133845 |
| FEI number | 3000718726 |
At a glance
- 1–9 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