FDAHealthOctober 21, 2025
Accriva Diagnostics, Inc. — 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 set
⚠️ Due to an device without a premarket clearance being incorrectly package and distributed.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 21, 2025
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.
What's affected?
- 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.
- Lot code
- WP1559-01
Additional details
Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01
What should I do?
Recommended action
Class III recall. Voluntary: Firm initiated Quantity affected: 125 boxes (3,125 tests).
Get Health recall alerts
Delivered to your inbox. Free. No account required.