Device recall
Z-1121-2022: The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor…
FDA device recall · Class II · Accriva Diagnostics, Inc.
Key facts
| Recall number (Z-number) | Z-1121-2022 |
|---|---|
| Recall event | 89936 |
| Product | The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor and the thienopyridine class of drugs, including clopidogrel and prasugrel.1-8 The test is based upon the ability of activated platelets to… |
| Product code | JOZ |
| Recalling firm | Accriva Diagnostics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 7, 2024 |
| 510(k) numbers | K141427 |
| FEI number | 2250033 |
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