FDA recall Z-0961-2025

Accriva Diagnostics, Inc. · Class II · device

Product

VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064

Reason for recall

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 inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor.

Distribution

US Nationwide distribution in the state of VA.

Key facts

Status: Ongoing
Initiation date: 2024-12-02
Report date: 2025-01-22
Voluntary/Mandated: Voluntary: Firm initiated
Location: San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0961-2025