Z-1018-04

VerifyNow Asprin Assay Kit Part No. 85034

Name: Z-1018-04 VerifyNow Asprin Assay Kit Part No. 85034
Creator: Accumetrics Inc
Published: 2004-05-10
License: https://open.fda.gov/license/

Accumetrics, Inc. / initiated 2004-05-10 / Terminated

FDA source

Accumetrics Inc began a recall of VerifyNow Asprin Assay Kit Part No. 85034 on 2004-05-10. The reason FDA records is "Test results too low in control". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1018-04
Status: Terminated
Initiated: 2004-05-10
Posted: 2004-07-20
Terminated: 2004-09-07
Recalling firm: Accumetrics, Inc.
Product: VerifyNow Asprin Assay Kit Part No. 85034
Product code: JOZ System, Automated Platelet Aggregation
Reason for recall: Test results too low in control.
FDA root cause: Other
Action: Letters were sent FEDEX on May 10, 2004. Customers were requested to discard the product. Distributors opted to return product. A response form was included to track materials.
Quantity in commerce: 4500
Distribution: Nationwide.
Product codes and lots: Assay Device Lot WD0034, Kit Lots W17105, W17140.

Product code JOZ

K012701Class IIUltegra System Rapid Platelet Function Assay - Asa (Rpfa-Asa)Accumetrics, Inc. / cleared 2002-06-12

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)