Z-0961-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 22, 2025
- Initiation Date
- December 2, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25
Product Description
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 Pattern
US Nationwide distribution in the state of VA.
Code Information
UDI-DI: 10711234150054. Lot: WL1145. Expiration: 2025-10-18