The VerifyNow P2Y12 Test is designed to measure platelet P2Y12… — Class II medical device recall Z-1121-2022
Terminated recall by Accriva Diagnostics, Inc., reported 2022-06-01, distributed nationwide. Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain
| Recall number | Z-1121-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accriva Diagnostics, Inc., San Diego, CA, United States |
| Recall initiated | 2022-03-30 |
| Classified | 2022-05-20 |
| Reported by FDA | 2022-06-01 |
| Terminated | 2024-11-07 |
| Distributed | Nationwide (US) |
| Quantity | 11 |
| Lot numbers | WL1060 |
| Expiration dates | 2023-03-01 |
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 and reports results in P2Y12 Reaction Units (PRU). The rate of microbead aggregation is more rapid and reproducible if platelets are activated; therefore, the reagent adenosine-5-diphosphate (ADP) is incorporated into the test channel to induce platelet activation. Prostaglandin E1 (PGE1) is included in the reagent mixture to increase the specificity of the PRU result to reflect P2Y12-mediated platelet aggregation. The reagents are formulated such to achieve reaction concentrations of 20 ¿M ADP and 22 nM PGE1. In a like manner, two other activators, iso-TRAP (Thrombin Receptor Activating Peptide) with PAR4-AP (PAR4-Activating Peptide) and fibrinogen-coated microparticles are incorporated into a second channel of the test device. The instrument measures the change in transmittance in this channel, calculates the baseline platelet function for the sample, and reports the percent inhibition result for the sample.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1121-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.