Device recall
Z-1823-2011: Calcium Reagent, Calcium Test System for COBAS INTEGRA 400, 400 PLUS, 800, 800…
FDA device recall · Class II · Roche Diagnostics Operations, Inc.
Key facts
| Recall number (Z-number) | Z-1823-2011 |
|---|---|
| Recall event | 57455 |
| Product | Calcium Reagent, Calcium Test System for COBAS INTEGRA 400, 400 PLUS, 800, 800 CTS, cobas c 311, 501 and 502, Part number 20763128322, Roche Diagnostics Corporation, Indianapolis, IN. For the in vitro quantitative determination of calcium in serum, plasma and urine. |
| Product code | CIC |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 13, 2011 |
| 510(k) numbers | K963292 |
| 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