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FDADecember 2, 2024device

VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

accriva diagnosticsaccriva

UPCs

10711234150054

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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