Device recall
Z-1400-2009: Remel Staphaurex Plus Kit, Catalog No. R30950102 (150 tests) and Catalog No…
FDA device recall · Class II · Remel, Inc
Key facts
| Recall number (Z-number) | Z-1400-2009 |
|---|---|
| Recall event | 51131 |
| Product | Remel Staphaurex Plus Kit, Catalog No. R30950102 (150 tests) and Catalog No. R30950201 (450 tests), rapid latex agglutination test for the identification of Staphylococcus aureus The responsible firm listed as Remel Europe Ltd, Dartford, England. |
| Product code | GTQ |
| Recalling firm | Remel, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 3, 2009 |
| FEI number | 1924669 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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