medical Class II Updated 2025-01-22

Accriva Diagnostics, Inc. recalls VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064

Recalled Product

VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI-DI: 10711234150054. Lot: WL1145. Expiration: 2025-10-18
View official government recall

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