Recall database

System, Automated Platelet Aggregation recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIIOngoingZ-0500-2026

Accriva Diagnostics, Inc. recalls VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 Th…

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

Automated Platelet Aggregation System
Under Investigation by firm

Accriva Diagnostics, I…CANov 19, 2025

Class IIOngoingZ-0961-2025

Accriva Diagnostics, Inc. recalls VerifyNow P2Y12 Platelet Reactivity Test

Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibit…

Automated Platelet Aggregation System
Process control

Accriva Diagnostics, I…CAJan 22, 2025