Device recall
Z-1008-2009: Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide…
FDA device recall · Class III · Remel, Inc
Key facts
| Recall number (Z-number) | Z-1008-2009 |
|---|---|
| Recall event | 50224 |
| Product | Dryspot (R) Staphytect Plus, Catalog #DR0100M, 120 tests/kit. Latex slide agglutination test for the differentiation of Staphylococcus aureus by detection of clumping factor, Protein A and certain polysaccharides found in methicillin-resistant S. aureus (MRSA) from those staphylococci that do not… |
| Product code | JWX |
| Recalling firm | Remel, Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jul 30, 2009 |
| 510(k) numbers | K972030 |
| FEI number | 1924669 |
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