Z-0500-2026Class III

VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a...

Name: Z-0500-2026 VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a...
Creator: Accriva Diagnostics, Inc.
Published: 2025-10-21
License: https://open.fda.gov/license/

Accriva Diagnostics, Inc. / initiated 2025-10-21 / Open, Classified / root cause: packaging

FDA source

Accriva Diagnostics, Inc. began a recall of VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of... on 2025-10-21. FDA classified it as Class III and gives the reason as "Due to an device without a premarket clearance being incorrectly package and distributed". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0500-2026
Classification: Class III
Status: Open, Classified
Initiated: 2025-10-21
Posted: 2025-11-13
Recalling firm: Accriva Diagnostics, Inc.
Product: VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade.
Product code: JOZ System, Automated Platelet Aggregation
Reason for recall: Due to an device without a premarket clearance being incorrectly package and distributed.
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: On 10/21/2025, the firm sent via email an "Urgent Medical Device Recall" Letter to customers informing them that Accriva Diagnostics, Inc. has identified that a small number of VerifyNow PRUTest Platelet Reactivity Test (85225) cartridge pouches from lot WP1559-01 may contain VerifyNow P2Y12 Test cartridges. VerifyNow P2Y12 Test cartridges are not cleared by the US-FDA for use in the United States. Customers are instructed to: 1. Please 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. Please check your inventory to determine if you have any boxes of VerifyNow PRU Platelet Reactivity Test (85225), lot number WP1559-01. If you have this product in stock, do NOT use. 4. Please sort through your inventory to identify if your inventory is affected. 5. Please destroy all impacted boxes and document on the enclosed form. 6. Please read the instructions on the Tracking Form and complete and return the form to Accriva Diagnostics, Inc. 7. If you have questions regarding replacement product, please contact Customer Service at 1-800-955-9525 or e-mail [email protected].
Quantity in commerce: 125 boxes (3,125 tests)
Distribution: Worldwide - U.S. Nationwide distribution in the states of AK, CA, FL, IA, IL, MD, MI, NY, SD, and TX. The countries of Hong Kong, Japan.
Product codes and lots: Catalog Number: 85225 UDI-DI code: 10711234150078 Lot Number: WP1559-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0500-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0500-2026	Class III	Ongoing	Voluntary: Firm initiated	2025-11-19	2025-11-13

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)