Device recall
Z1006-2010: FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument. Material Number…
FDA device recall · Class II · Roche Molecular Systems, Inc.
Key facts
| Recall number (Z-number) | Z1006-2010 |
|---|---|
| Recall event | 53708 |
| Product | FACTOR II (PROTHROMBIN) G20210A Kit, LightCycler 2.0 Instrument. Material Number 03610195 001 Cont. 1 FIIG20210A MD Mix, 1 x 78 uL 2. FIIG20210A R mix, 1 x 78 uL 3. FIIG20210A CT, 1 x 50 uL 5, FIIG20210A DIL 1 x 1 mL Manufactured in Germany Distributed by Roche Diagnostics, Indianapolis, IN |
| Product code | NPR |
| Recalling firm | Roche Molecular Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 9, 2010 |
| 510(k) numbers | K033612 |
| FEI number | 2243471 |
At a glance
- 1–9 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