Z-0961-2025Class II

VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064

Name: Z-0961-2025 VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Creator: Accriva Diagnostics, Inc.
Published: 2024-12-02
License: https://open.fda.gov/license/

Accriva Diagnostics, Inc. / initiated 2024-12-02 / Open, Classified / root cause: manufacturing process

FDA source

Accriva Diagnostics, Inc. began a recall of VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064 on 2024-12-02. FDA classified it as Class II and gives the reason as "Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0961-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-12-02
Posted: 2025-01-16
Recalling firm: Accriva Diagnostics, Inc.
Product: VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Product code: JOZ System, Automated Platelet Aggregation
Reason for recall: Platelet Reactivity Test distributed without appropriate US-FDA market clearance; if used healthcare personnel could use the baseline PRUTest measurement prior to initiating drug therapy, and then use the percent inhibition formula in the notice to manually calculate the percentage of platelet aggregation inhibition for a given patient receiving drug treatment with P2Y12 receptor inhibitor.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 12/02/2024, a recall notice was mailed to the customer who was asked to do the following: 1.Forward this communication to those within your organization who need to become aware of this matter and verify they understand the procedure and can complete the enclosed forms. 2. In addition, forward the enclosed customer notification to all other organizations where affected devices may have been transferred to. 3. Destroy all impacted boxes. 4. Complete and return the tracking form via email to [email protected] If you have questions regarding replacement product, please contact the firm's Customer Service at 800-955-9525 or e-mail [email protected].
Quantity in commerce: 25
Distribution: US Nationwide distribution in the state of VA.
Product codes and lots: UDI-DI: 10711234150054. Lot: WL1145. Expiration: 2025-10-18

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0961-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0961-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-01-22	2025-01-16

Product code JOZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)