Device recall
Z-1535-2015: CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage…
FDA device recall · Class II · Biocare Medical, LLC
Key facts
| Recall number (Z-number) | Z-1535-2015 |
|---|---|
| Recall event | 70823 |
| Product | CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods. |
| Product code | NJT |
| Recalling firm | Biocare Medical, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 15, 2015 |
| 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