Device recall
Z-0484-2013: Data Station AMPLILINK software is an instrument user interface/ data management…
FDA device recall · Class II · Roche Molecular Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0484-2013 |
|---|---|
| Recall event | 63312 |
| Product | Data Station AMPLILINK software is an instrument user interface/ data management software used with COBAS AmpliPrep instrument, COBAS TaqMan analyzer, COBAS TaqMan 48 analyzer, COBAS AMPLICOR analyzer, and Cobas p 630 instrument for sample preparation, amplification and detection of PCR (Polymerase… |
| Product code | NSX |
| Recalling firm | Roche Molecular Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 22, 2015 |
| FEI number | 2243471 |
At a glance
- None Linked 510(k)s
- 10–99 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