VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 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.
Due to an device without a premarket clearance being incorrectly package and distributed.
From the FDA notice · Read the official notice ↗ · All Accriva Diagnostics recalls
What to do
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- Product
- VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 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.
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 125 boxes (3,125 tests)
- Illnesses reported
- None reported
- Manufactured in
- 6260 Sequence Dr, San Diego, CA, United States
- Classification
- Class III
- Recall number
- Z-0500-2026
In the FDA's words
- Description
- VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 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. Due to an device without a premarket clearance being incorrectly package and distributed. Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01 Distribution: Worldwide - U.S. Nationwide distribution in the states of AK, CA, FL, IA, IL, MD, MI, NY, SD, and TX. The countries of Hong Kong, Japan. Affected quantity: 125 boxes (3,125 tests)
- Hazard
- Due to an device without a premarket clearance being incorrectly package and distributed.
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ModerateFDAOct 30, 2026