Device product
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.
Z-0500-2026
Product summary
- Event
- Event 97863
- Status
- Ongoing
- Classification
- Class III
- Quantity
- 125 boxes (3,125 tests)
- Official record key
device-enforcement:Z-0500-2026
Official wording
Reason: Due to an device without a premarket clearance being incorrectly package and distributed.
Code information: Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01
Distribution pattern: Worldwide - U.S. Nationwide distribution in the states of AK, CA, FL, IA, IL, MD, MI, NY, SD, and TX. The countries of Hong Kong, Japan.
Derived failure modes
-
Unknown
Due to an device without a premarket clearance being incorrectly package and distributed.