Z-1121-2022Class II

The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to...

Name: Z-1121-2022 The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to...
Creator: Accriva Diagnostics, Inc.
Published: 2022-03-30
License: https://open.fda.gov/license/

Accriva Diagnostics, Inc. / initiated 2022-03-30 / Terminated / root cause: manufacturing process

FDA source

Accriva Diagnostics, Inc. began a recall of The VerifyNow P2Y12 Test is designed to measure platelet P2Y12 receptor blockade. Substances known to specifically block the P2Y12 receptor include ticagrelor... on 2022-03-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1121-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-30
Posted: 2022-05-20
Terminated: 2024-11-07
Recalling firm: Accriva Diagnostics, Inc.
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.
Product code: JOZ System, Automated Platelet Aggregation
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.
Root cause tag: manufacturing process
FDA 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 [email protected]
Quantity in commerce: 11
Distribution: US Nationwide distribution in the state of California.
Product codes and lots: Lot Number: WL1060, Expiration: 2023-03-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1121-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1121-2022	Class II	Terminated	Voluntary: Firm initiated	2022-06-01	2022-05-20

Product code JOZ

K141427Class IIAccumetrics,inc. Verifynow Prutest, Accumetrics, Inc. Verifynow PrutestAccumetrics, Inc. / cleared 2015-07-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)