Device recall
Z-0818-2010: Staphytect Plus, packaged in 100- and 500-test boxes, Catalog #DR0850M (100…
FDA device recall · Class II · Remel, Inc
Key facts
| Recall number (Z-number) | Z-0818-2010 |
|---|---|
| Recall event | 53553 |
| Product | Staphytect Plus, packaged in 100- and 500-test boxes, Catalog #DR0850M (100 tests) and #DR0850B (500 tests). Oxoid Ltd., Wade Road, Basingstoke, Hants UK. Latex slide agglutination test for the differentiation of staphylococcus aureus by detection of clumping factor, Protein A and certain… |
| Product code | JWX |
| Recalling firm | Remel, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 25, 2012 |
| 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