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Recall Observatory FDA recall evidence

Device 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.

Z-0500-2026

October 21, 2025

Class III

Product summary

Firm
Accriva Diagnostics, Inc.
Event
Event 97863
Status
Ongoing
Classification
Class III
Quantity
125 boxes (3,125 tests)
Official record key
device-enforcement:Z-0500-2026

Official wording

Reason: Due to an device without a premarket clearance being incorrectly package and distributed.

Code information: Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to an device without a premarket clearance being incorrectly package and distributed.