Z-0771-04

Coag-A-Mate MTX and MTX II Instrument Operator Manual

Name: Z-0771-04 Coag-A-Mate MTX and MTX II Instrument Operator Manual
Creator: Biomerieux, Inc.
Published: 2003-09-29
License: https://open.fda.gov/license/

bioMerieux, Inc. / initiated 2003-09-29 / Terminated

FDA source

Biomerieux, Inc. began a recall of Coag-A-Mate MTX and MTX II Instrument Operator Manual on 2003-09-29. The reason FDA records is "Typographical error in the Operator Manual. In Chapter 11 of the MTX/MTX II Operator Manual, the numerical range for the Warning Flag is shown as 00-99. The correct numerical range is 0-99. The 'list of error and...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0771-04
Status: Terminated
Initiated: 2003-09-29
Posted: 2004-07-20
Terminated: 2005-06-08
Recalling firm: bioMerieux, Inc.
Product: Coag-A-Mate MTX and MTX II Instrument Operator Manual
Product code: GKP Instrument, Coagulation, Automated
Reason for recall: Typographical error in the Operator Manual. In Chapter 11 of the MTX/MTX II Operator Manual, the numerical range for the Warning Flag is shown as 00-99. The correct numerical range is 0-99. The 'list of error and warning' chart shows a numerical range representing the codes 00-9. The correct numerical range for the first ten error/warning codes are 0-9.
FDA root cause: Other
Action: Consignees were notified by letter on September 29, 2003.
Quantity in commerce: unknown
Distribution: Nationwide, Argentina, Australia, Austria, Belgium, Brazil, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Finland, France, Germany, Greece, HK, India, Italy, Ivory Coast, Japan, Korea, Mexico, Netherlands, N. Zealand, Norway, Poland, Portugal, Russia, Spain, Sweden, Switzerland, Turkey, UK.
Product codes and lots: All Codes

Product code GKP

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)