Recall Z-0771-04 ยท GKP Instrument, Coagulation, Automated
Biomerieux, Inc.
Coag-A-Mate MTX and MTX II Instrument Operator Manual
| Date | Jul 20, 2004 (initiated Sep 29, 2003) |
| Status | Terminated |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.