Accriva Diagnostics, Inc. recalls VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood…

Recall date

October 21, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0500-2026

FDA classification

Class III

Brand / firm

Accriva Diagnostics, Inc.

Sold / distributed

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.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.