Device recall
Z-1172-2014: VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011…
FDA device recall · Class II · Accumetrics Inc
Key facts
| Recall number (Z-number) | Z-1172-2014 |
|---|---|
| Recall event | 67508 |
| Product | VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Product Usage: The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality… |
| Product code | JOZ |
| Recalling firm | Accumetrics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 23, 2014 |
| 510(k) numbers | K011337, K013596, K992531 |
| 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