Device recall
Z-0482-2014: VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total…
FDA device recall · Class II · Accumetrics Inc
Key facts
| Recall number (Z-number) | Z-0482-2014 |
|---|---|
| Recall event | 66834 |
| Product | VerifyNow IIb/IIIa Test, 10-Test Kit, Catalog No. 85310, 10 tests/box; 690 total tests. The VerifyNow IIb/IlIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) lIb/IlIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow… |
| Product code | JOZ |
| Recalling firm | Accumetrics Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 23, 2013 |
| 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