Device recall
Z-2350-2015: PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex…
FDA device recall · Class II · Remel Inc
Key facts
| Recall number (Z-number) | Z-2350-2015 |
|---|---|
| Recall event | 71614 |
| Product | PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or G from primary culture plates. |
| Product code | GTY |
| Recalling firm | Remel Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 13, 2017 |
| FEI number | 1924669 |
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