Medical Device Recall: VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Accriva Diagnostics, Inc. · December 2, 2024
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.
States Affected
NATIONWIDE
Quantity Affected
25
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0961-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.