Reported Nov 19, 2025 · Ongoing
VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood…
Accriva Diagnostics, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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 PRUTest Platelet
- Reactivity Test REF 85225 UDI-DI code10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade
- Lot codes and dates
- Catalog Number85225
- UDI-DI code10711234150078
- Lot NumberWP1559-01
- Amount recalled
- 125 boxes (3,125 tests)
Where it was sold
Why it was recalled
Due to an device without a premarket clearance being incorrectly package and distributed.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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