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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm April 28, 2003
Date Posted July 30, 2003
Recall Status1 Terminated 3 on April 20, 2004
Recall Number Z-1071-03
Recall Event ID 26359
Product Coulter Clone B6-FITC Reagent
Code Information Lots 735512F, 735513F and 735514FR
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
For Additional Information Contact Kathleen M. Jaker
714-961-3666
Manufacturer 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 122
Distribution Nationwide and to Canada
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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