Device recall
Z-3123-2017: Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for…
FDA device recall · Class II · Leica Biosystems Richmond Inc.
Key facts
| Recall number (Z-number) | Z-3123-2017 |
|---|---|
| Recall event | 78055 |
| Product | Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autosomal dominant condition… |
| Product code | NJT |
| Recalling firm | Leica Biosystems Richmond Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 2, 2024 |
| FEI number | 1419341 |
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