Z-0500-2026 Class III Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 19, 2025
- Initiation Date
- October 21, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 125 boxes (3,125 tests)
Product Description
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.
Reason for Recall
Due to an device without a premarket clearance being incorrectly package and distributed.
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.
Code Information
Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01