FDA Medical Device Recalls (openFDA)
Biomerieux, Inc.: Coag-A-Mate MTX and MTX II Instrument Operator Manual
- Recall number
- Z-0771-04
- Recalling firm
- Biomerieux, Inc.
- Product
- Coag-A-Mate MTX and MTX II Instrument Operator Manual
- Status
- Terminated
- Initiated
- 2003-09-29
- Posted
- 2004-07-20
- Terminated
- 2005-06-08
- Reason
- 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.
- Root cause
- Other
- Action
- Consignees were notified by letter on September 29, 2003.
- Quantity
- 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.
- Lot, serial or model codes
- All Codes
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GKP
- Firm FEI
- 1039284
- Firm city
- Durham
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28