Accriva Diagnostics, Inc. recalls VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
- Recall date
- December 2, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0961-2025
- FDA classification
- Class II
- Brand / firm
- Accriva Diagnostics, Inc.
- Sold / distributed
- US Nationwide distribution in the state of VA.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
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