VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNo...
FDA Recall #Z-0500-2026 — Class III — October 21, 2025
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.
Recalling Firm
Accriva Diagnostics, Inc. — San Diego, CA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Devices
Product Quantity
125 boxes (3,125 tests)
Distribution
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated