Class II — Accriva Diagnostics, Inc.
| Recalling firm | Accriva Diagnostics, Inc. |
|---|---|
| Registered facility | Accriva Diagnostics, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test without US-FDA market clearance was distributed and it displays BASE results not displayed by the US-FDA market cleared device. A formula is being provided to health care personnel to calculate the percentage of platelet aggregation inhibition. |
| Product | The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor and the thienopyridine class of drugs, including clopidogrel and prasugrel.1-8 The test is based upon the ability of activated platelets to bind fibrinogen. Fibrinogen-coated microparticles aggregate in whole blood in proportion to the number of expressed platelet GP IIb/IIIa receptors. Light transmittance increases as activated platelets bind and aggregate fibrinogen-coated beads. The instrument measures this change in optical signal an… |
| Quantity | 11 |
| Distribution | US Nationwide distribution in the state of California. |
| Initiated | 2022-03-30 |
| Classified | 2022-05-20 |
| Terminated | 2024-11-07 |
| Recall number | Z-1121-2022 |
| 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 II recall — Accriva Diagnostics, Inc. (Z-1121-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89936/
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