FDA Recall
Terminated
Synchron LX Clinical Systems Software
Recall: Z-1116-04
·
Initiated October 7, 2003
Recall
- Recall Number
- Z-1116-04
- Event Number
- 29117
- Firm
- Beckman Coulter Inc
- FEI Number
- 2050012
- Status
- Terminated
- Root Cause
- Other
- Initiated
- October 7, 2003
- Posted
- July 20, 2004
- Terminated
- August 30, 2004
- Address
- 200 S Kraemer Blvd, Brea, CA, 92822-6208
Description
Synchron LX Clinical Systems Software
Reason
'Initial Rate High' parameter for User Defined Reagents does not perform as indicated in the Synchron LX Clinical Systems Operations Manual.