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Accriva Diagnostics, Inc. recalls VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole bl
Recalled November 19, 2025 · FDA recall Z-0500-2026 · Accriva Diagnostics
Hazard
Due to an device without a premarket clearance being incorrectly package and distributed. · FDA Class III
Units
125 boxes (3,125 tests)
Sold at
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.
Description
Due to an device without a premarket clearance being incorrectly package and distributed.
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.
Manufacturer(s)
Accriva Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →