Z-1854-2012Class II

VerifyNow System, part #85005-6H

Name: Z-1854-2012 VerifyNow System, part #85005-6H
Creator: Accumetrics Inc
Published: 2012-02-06
License: https://open.fda.gov/license/

Accumetrics, Inc. / initiated 2012-02-06 / Terminated

FDA source

Accumetrics Inc began a recall of VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to... on 2012-02-06. FDA classified it as Class II and gives the reason as "The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1854-2012
Classification: Class II
Status: Terminated
Initiated: 2012-02-06
Posted: 2012-06-21
Terminated: 2012-11-27
Recalling firm: Accumetrics, Inc.
Product: VerifyNow System, part #85005-6H Product Usage: The VerifyNow P2Y12 assay device is a whole blood assay used in the laboratory or point of care setting to measure the level of platelet P2Y12 receptor blockade. The VerifyNow Systems intended for use with human whole blood and verify now test devices. The system should be operated by healthcare professionals trained on use of the system and in accordance with institution and policies and procedures. Accumetrics respresentatives will assist your institution in the installation of the system and operations of the operator.
Product code: JOZ System, Automated Platelet Aggregation
Reason for recall: The recall was initiated by Accumetrics because of a field correction to the VerifyNow System; specifically the results reported when running the VerifyNow P2Y12 Test. Currently the VerifyNow P2Y12 Test reports three values: PRU, BASE and % Inhibition. The change implemented is the elimination of the BASE and % Inhibition results. There will be no change to the reporting of the PRU result whic
FDA root cause: No Marketing Application
Action: Accumetrics, Inc. sent an Urgent Field Correction notification letter and an Ackknowledgement - fax back form to all affected customers. The letter identifed the affected product, problem and actions to be taken. The letter informed customers that an Accumetrics representative will be contacting them to schedule an appointment to update their VerifyNow instrument software. The letter stated that Accumetrics realizes that procedures and report format may need to be revised as software changes is implemented, and will provide assistance to help in making this transition. For any questions or concerns, call at 1-800-643-1640 ext. 2; or email at: [email protected].
Quantity in commerce: 1,167 units total
Distribution: US Nationwide Distribution
Product codes and lots: Not available

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1854-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1853-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-21
Z-1854-2012	Class II	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-21

Product code JOZ

K051231Class IIVerifynow-P2y12 AssayAccumetrics, Inc. / cleared 2005-08-05

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)