FDA-Device2025-11-19Class IIIPACKAGING DEFECT
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.
Hazard
Due to an device without a premarket clearance being incorrectly package and distributed.
Intended for
Adults
Illnesses reported
None reported
Sold states
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 count
125 boxes (3,125 tests)
Manufactured in
6260 Sequence Dr, San Diego, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0500-2026More Accriva Diagnostics recalls
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