FDA Recall
Terminated
DL 2000 Data Manager, Software Version 6.2
Recall: Z-1027-04
·
Initiated February 14, 2004
Recall
- Recall Number
- Z-1027-04
- Event Number
- 28932
- Firm
- Beckman Coulter Inc
- FEI Number
- 2050012
- Status
- Terminated
- Root Cause
- Other
- Initiated
- February 14, 2004
- Posted
- July 20, 2004
- Terminated
- December 2, 2004
- Address
- 200 S Kraemer Blvd, Brea, CA, 92822-6208
Description
DL 2000 Data Manager, Software Version 6.2
Reason
Software defect. The type of results affected were replicate type results for a single sample transmitted within the same data stream.
Action
Recall is complete. Letters were mailed to customers on 2/14/2003. Instruments received upated software version 6.3.
Distribution
Nationwide.
Quantity
231