Class III — Accriva Diagnostics, Inc.
| Recalling firm | Accriva Diagnostics, Inc. |
|---|---|
| Registered facility | Accriva Diagnostics, Inc. (the firm's only registered facility) |
| Classification | Class III |
| Status | Ongoing |
| Reason | Due to an device without a premarket clearance being incorrectly package and distributed. |
| 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. |
| Quantity | 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. |
| Initiated | 2025-10-21 |
| Classified | 2025-11-13 |
| Recall number | Z-0500-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class III recall — Accriva Diagnostics, Inc. (Z-0500-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97863/
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