Recall Z-1121-2022 ยท JOZ System, Automated Platelet Aggregation
Accriva Diagnostics, Inc.
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 numbe
| Date | Mar 30, 2022 |
| 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. |
| Root cause | Employee error |
| Action | On 03/30/22, recall notices were distributed to customers who were asked to do the following: 1) Forward the notice within their organization and all other organizations where affected devices may have been transferred to. 2) Identify affected devices and do not use. 3) Destroy all affected devices and document the destruction on the Tracking Form. 4) Complete and return the Tracking Form to the recalling firm. Customers with additional questions can contact Customer Service at 800-955-9525 or e-mail customerservice.na@werfen.com |
| Quantity | 11 |
| Distribution | US Nationwide distribution in the state of California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141427 | ACCUMETRICS,INC. VERIFYNOW PRUTEST, ACCUMETRICS, INC. VERIFYNOW PRUTEST Accumetrics, Inc., Jul 24, 2015 |