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U.S. Department of Health and Human Services

Class 2 Device Recall Beckman Coulter

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  Class 2 Device Recall Beckman Coulter see related information
Date Initiated by Firm August 26, 2003
Date Posted October 15, 2003
Recall Status1 Terminated 3 on April 20, 2004
Recall Number Z-0046-04
Recall Event ID 27323
Product Classification Counter, Differential Cell - Product Code GKZ
Product Cyto-Stat Tetra Chrome CD45-FITC/CD56-RD-1/CD-19-ECD/CD3-PC5 Monoclonal Antibody Reagent
Code Information Lot 758031F1, Part number 6607073
Recalling Firm/
Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
For Additional Information Contact Kathleen Jaker
Manufacturer Reason
for Recall
Package insert contains inaccurate information.
FDA Determined
Cause 2
Quantity in Commerce 233
Distribution United States and Canada
Total Product Life Cycle TPLC Device Report

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.