Device recall
Z-1045-2012: SLIDEX Staph kit (250 Tests). The SLIDEX Staph-Kit is a rapid latex and red…
FDA device recall · Class II · bioMerieux, Inc.
Key facts
| Recall number (Z-number) | Z-1045-2012 |
|---|---|
| Recall event | 60990 |
| Product | SLIDEX Staph kit (250 Tests). The SLIDEX Staph-Kit is a rapid latex and red blood cell agglutination test for the identification of Staphylococcus aureus strains from culture media. |
| Product code | JWX |
| Recalling firm | bioMerieux, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 17, 2013 |
| 510(k) numbers | K923212 |
| FEI number | 3002769706 |
At a glance
- 1–9 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