FDA Recall
Terminated
Coulter LH 700 Series and GEN S Hematology Analyzers 864.5220 Automated differential cell counter
Recall: Z-0571-03
·
Initiated December 10, 2002
Recall
- Recall Number
- Z-0571-03
- Event Number
- 25484
- Firm
- Beckman Coulter Inc
- FEI Number
- 2050012
- Status
- Terminated
- Root Cause
- Other
- Initiated
- December 10, 2002
- Posted
- February 25, 2003
- Terminated
- April 21, 2004
- Address
- 200 South Kraemer Blvd W, 337, Brea, CA, 92822
Description
Coulter LH 700 Series and GEN S Hematology Analyzers 864.5220 Automated differential cell counter
Reason
Device design allows for cross contamination issue to occur, possibly affecting assays and results reports.
Action
Firm will check and shorten sweepflow tubing on a next visit basis during routine service visits.
Distribution
Nationwide and Canada
Quantity
447