Device recall
Z-2566-2011: Factor V Leiden Kit Light Cycler Instrument; Manufactured in Germany for Roche…
FDA device recall · Class II · Roche Molecular Systems, Inc.
Key facts
| Recall number (Z-number) | Z-2566-2011 |
|---|---|
| Recall event | 58747 |
| Product | Factor V Leiden Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA; Distributed by Roche Diagnostics Indianapolis, IN 46266 USA; 03610179001. For use with Light Cycler 2.0 instrument; The Factor V Leiden Kit allows the detection and… |
| Product code | NPQ |
| Recalling firm | Roche Molecular Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 13, 2012 |
| FEI number | 2243471 |
At a glance
- None 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