Medical Device Recall: 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
Accriva Diagnostics, Inc. · October 21, 2025
Reason for Recall
Due to an device without a premarket clearance being incorrectly package and distributed.
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.
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.
States Affected
NATIONWIDE
Quantity Affected
125 boxes (3,125 tests)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0500-2026
Status: ongoing
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