FDAClass IIINovember 19, 2025

VerifyNow PRUTest Platelet Reactivity Test 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…

Why was VerifyNow PRUTest Platelet Reactivity Test recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Accriva Diagnostics, Inc.
Quantity
125 boxes (3,125 tests)
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.
Recall date
November 19, 2025
Classification
Class III
Status
Ongoing
Agency
FDA (device)
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