Device recall
Z-1680-2011: Acetaminophen Test System for use on the COBAS/INTEGRA/cobas c, part number…
FDA device recall · Class II · Roche Diagnostics Operations, Inc.
Key facts
| Recall number (Z-number) | Z-1680-2011 |
|---|---|
| Recall event | 57513 |
| Product | Acetaminophen Test System for use on the COBAS/INTEGRA/cobas c, part number 20767174322, Roche Diagnostics Corporation, Indianapolis, IN. For the quantitative determinations of toxic levels of acetaminophen in human serum or plasma on Roche automated clinical analyzers. |
| Product code | LDP |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 13, 2012 |
| 510(k) numbers | K991598 |
| FEI number | 1823260 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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