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Accriva Diagnostics, Inc. recalls VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Recalled January 22, 2025 · FDA recall Z-0961-2025 · Accriva Diagnostics
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. · FDA Class II
Units
25
Sold at
US Nationwide distribution in the state of VA.
Description
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.
Product
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Manufacturer(s)
Accriva Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →