—#28579

Product

Coulter Clone B6-FITC Reagent

Affected lot / code info: Lots 735512F, 735513F and 735514FR

Why it was recalled

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.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 South Kraemer Blvd W, 337, Brea, California 92822

Distribution

Distribution pattern: Nationwide and to Canada

Timeline

Recall initiated: 2003-04-28
Posted by FDA: 2003-07-30
Terminated: 2004-04-20
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #28579. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.