FDA recall Z-0500-2026

Accriva Diagnostics, Inc. · Class III · 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.

Reason for recall

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

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.

Key facts

Status: Ongoing
Initiation date: 2025-10-21
Report date: 2025-11-19
Voluntary/Mandated: Voluntary: Firm initiated
Location: San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0500-2026