VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Low |
| Status | ongoing |
| Recall date | October 21, 2025 |
| Reported | November 19, 2025 |
| Recalling firm | Accriva Diagnostics, Inc. |
| Country / region | United States CA |
Hazard
Due to an device without a premarket clearance being incorrectly package and distributed.
Affected products
- VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point
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