Z-0043-05

The MDA system with MDA Antithrombin III MDA Heparin

Name: Z-0043-05 The MDA system with MDA Antithrombin III MDA Heparin
Creator: bioMerieux
Published: 2004-06-11
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2004-06-11 / Terminated

FDA source

bioMerieux began a recall of The MDA system with MDA Antithrombin III MDA Heparin on 2004-06-11. The reason FDA records is "The firm received complaints regarding an observed bias in percent activity between capped and uncapped specimens". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0043-05
Status: Terminated
Initiated: 2004-06-11
Posted: 2004-10-23
Terminated: 2005-06-07
Recalling firm: bioMerieux, Inc.
Product: The MDA system with MDA Antithrombin III MDA Heparin
Product code: JPA System, Multipurpose For In Vitro Coagulation Studies
Reason for recall: The firm received complaints regarding an observed bias in percent activity between capped and uncapped specimens.
FDA root cause: Other
Action: Consignees were initially notified by letter on June 11, 2004. A follow up letter was sent to consignees, via Fedex on July 9, 2004.
Distribution: Nationwide, Australia, Belgium, Brazil, Canada, China, Germany, Italy, Japan, Taiwan, UK
Product codes and lots: All product numbers

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)