Device recall
Z-1111-2010: Wampole Staph Latex Test, 6.0 ml -120 Test Kit For In Vitro Diagnostic Use…
FDA device recall · Class II · NERL Diagnostics Corporation
Key facts
| Recall number (Z-number) | Z-1111-2010 |
|---|---|
| Recall event | 54267 |
| Product | Wampole Staph Latex Test, 6.0 ml -120 Test Kit For In Vitro Diagnostic Use Catalog Number: 56D6 Manufactured for; Wampole Laboratories Cranbury, New Jersey 08512 A rapid latex agglutination test to detect Protein A and/or clumping factor for Staph aureus from culture media. |
| Product code | JWX |
| Recalling firm | NERL Diagnostics Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 5, 2011 |
| FEI number | 1215667 |
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