Coag-A-Mate MTX and MTX II Instrument Operator Manual
FDA device recall Z-0771-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Biomerieux, Inc.
- 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.
- Action taken
- Consignees were notified by letter on September 29, 2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- GKP
- Quantity affected
- 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, Mex
- Date initiated
- 2003-09-29
- Date posted
- 2004-07-20
- Date terminated
- 2005-06-08
- Location
- Durham, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.