Device recall
Z-1998-2011: Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics…
FDA device recall · Class III · Roche Diagnostics Operations, Inc.
Key facts
| Recall number (Z-number) | Z-1998-2011 |
|---|---|
| Recall event | 56636 |
| Product | Cyclosporine Sample Pretreatment Reagent, COBAS INTEGRA, IVD, Roche Diagnostics GmbH, Assembled for and Distributed by: Roche Diagnostics Corporation, Indianapolis, IN. For the quantitative determination of Cyclosporine in whole blood, using automated clinical analyzers as an aid in management of… |
| Product code | MKW |
| Recalling firm | Roche Diagnostics Operations, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | May 4, 2011 |
| FEI number | 1823260 |
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