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Z-0500-2026Class III

Accriva Diagnostics, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Accriva Diagnostics, Inc.
Product type
Device
Status
Ongoing
Report date
2025-11-19
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.
Firm state
CA
Product quantity
125 boxes (3,125 tests)
Initiated by
Voluntary: Firm initiated
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.

Code / lot info

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

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →