Device recall
Z-0252-2016: Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers…
FDA device recall · Class II · Biocare Medical, LLC
Key facts
| Recall number (Z-number) | Z-0252-2016 |
|---|---|
| Recall event | 72160 |
| Product | Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted and ready to use. They are the same product with the same intended use. Chemistry - IVD Smooth Muscle Actin (SMA) antibody recognizes the alpha-smooth muscle… |
| Product code | NJT |
| Recalling firm | Biocare Medical, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 11, 2016 |
| FEI number | 3004140393 |
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