Z-0032-06

VeriCal Calibrator Set

Name: Z-0032-06 VeriCal Calibrator Set
Creator: Biomerieux, Inc.
Published: 2005-08-19
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2005-08-19 / Terminated

FDA source

BIOMERIEUX, INC. began a recall of VeriCal Calibrator Set on 2005-08-19. The reason FDA records is "The product is being recalled due to mis-assignment of ISI values associated with VeriCal use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0032-06
Status: Terminated
Initiated: 2005-08-19
Posted: 2005-10-22
Terminated: 2006-10-16
Recalling firm: bioMerieux, Inc.
Product: VeriCal Calibrator Set
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: The product is being recalled due to mis-assignment of ISI values associated with VeriCal use.
FDA root cause: Other
Action: Consignees were notified on/about 08/31/2005.
Quantity in commerce: 2334 kits
Distribution: Nationwide
Product codes and lots: Lots 161813, 161907, 161908, 161909

Product code JPA

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)