Reported Jan 22, 2025 · Ongoing
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Accriva Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accriva Diagnostics, Inc. · 6260 Sequence Dr · San Diego, CA · 92121-4358
Is this the product you have?
- VerifyNow P2Y12 Platelet Reactivity Test
- REF85064
- Lot codes and dates
- UDI-DI10711234150054
- LotWL1145
- Expiration2025-10-18
- Amount recalled
- 25
Where it was sold
- Nationwide
- 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.
This product could cause temporary or reversible health problems — stop using it.
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