Drug recall
The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to…
FDA recall event 89936 · Class II · Accriva Diagnostics, Inc.
Key facts
| Event ID | 89936 |
|---|---|
| Recall numbers | Z-1121-2022 |
| Recalling firm | Accriva Diagnostics, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Mar 30, 2022 |
| Report date | Jun 1, 2022 |
| Termination date | Nov 7, 2024 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 2250033 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: