Beckman Coulter Inc Coulter Clone B6-FITC Reagent Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Coulter Clone B6-FITC Reagent
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Lots 735512F, 735513F and 735514FR
Products Sold
Lots 735512F, 735513F and 735514FR
Beckman Coulter Inc is recalling Coulter Clone B6-FITC Reagent due to Diminished expression on B-Cell populations when drawn in EDTA tubes, which may lead to inaccurate interpretation of phenotype results. It was deter. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026