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 number of expressed platelet GP IIb/IIIa receptors. Light transmittance increases as activated platelets Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Accriva Diagnostics, Inc.
Lot Codes / Batch Numbers
Lot Number: WL1060, Expiration: 2023-03-01
Products Sold
Lot Number: WL1060, Expiration: 2023-03-01
Accriva Diagnostics, Inc. is recalling The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known t due to Two whole blood Platelet Reactivity tests exist that share the same reagent formulation and are used to obtain P2Y12 Reactivity Unit results. The test. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026