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Accriva Diagnostics, Inc.: VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the

Medical DevicesSource: FDA (device) · Date: 2025-11-19

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Accriva Diagnostics, Inc.
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.
Reason / hazard
Due to an device without a premarket clearance being incorrectly package and distributed.
Classification
Class III
Status
Ongoing
Distribution / 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.
Recall initiated
2025-10-21
Code info
Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01
Product quantity
125 boxes (3,125 tests)
Voluntary mandated
Voluntary: Firm initiated
City
San Diego
State
CA
Country
United States
Event id
97863
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