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.
Reported: November 19, 2025 Initiated: October 21, 2025 #Z-0500-2026
Product 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.
Reason for Recall
Due to an device without a premarket clearance being incorrectly package and distributed.
Details
- Recalling Firm
- Accriva Diagnostics, Inc.
- Units Affected
- 125 boxes (3,125 tests)
- 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.
- Location
- San Diego, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Accriva Diagnostics, Inc.. Units affected: 125 boxes (3,125 tests).
Why was this product recalled? ▼
Due to an device without a premarket clearance being incorrectly package and distributed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 19, 2025. Severity: Low. Recall number: Z-0500-2026.
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