Device recall
Z-1854-2012: VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device…
FDA device recall · Class II · Accumetrics Inc
Key facts
| Recall number (Z-number) | Z-1854-2012 |
|---|---|
| Recall event | 61761 |
| Product | VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices… |
| Product code | JOZ |
| Recalling firm | Accumetrics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 27, 2012 |
| 510(k) numbers | K051231 |
| FEI number | 3001376288 |
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