Coulter Clone B6-FITC Reagent
FDA device recall Z-1071-03 · posted 2003-07-30 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- Reason for recall
- 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 taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Quantity affected
- 122
- Distribution
- Nationwide and to Canada
- Date initiated
- 2003-04-28
- Date posted
- 2003-07-30
- Date terminated
- 2004-04-20
- Location
- Brea, CA
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