Coag-A-Mate MTX and MTX II Instrument Operator Manual
This recall has been terminated (originally issued July 20, 2004).
- Company
- Biomerieux, Inc.
- Recall Initiated
- September 29, 2003
- Posted
- July 20, 2004
- Terminated
- June 8, 2005
- Recall Number
- Z-0771-04
- Quantity
- unknown
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
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.
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 / Code Info
All Codes
Root Cause
Other
Action Taken
Consignees were notified by letter on September 29, 2003.