FDA Recall
Terminated
Coulter Clone B6-FITC Reagent
Recall: Z-1071-03
·
Initiated April 28, 2003
Recall
- Recall Number
- Z-1071-03
- Event Number
- 26359
- Firm
- Beckman Coulter Inc
- FEI Number
- 2050012
- Status
- Terminated
- Root Cause
- Other
- Initiated
- April 28, 2003
- Posted
- July 30, 2003
- Terminated
- April 20, 2004
- Address
- 200 South Kraemer Blvd W, 337, Brea, CA, 92822
Description
Coulter Clone B6-FITC Reagent
Reason
Diminished expression on B-Cell populations when drawn in EDTA tubes, which may lead to inaccurate interpretation of phenotype results. It was determined that choice of anticoagulant may have an effect on results for this reagent. The CD23 clone has shown a diminished expression on B-Cell populations when drawn on EDTA tubes, which may lead to inaccurate interpretation of phenotype results.
Action
Customer letters will be sent to all known purchasers on or about 4/28/2003, also existing inventory will be reworked to include a letter describing performance issues when collection occurs using EDTA.
Distribution
Nationwide and to Canada
Quantity
122