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/ Manufacturer |
Beckman Coulter Inc 200 South Kraemer Blvd W 337 Brea CA 92822
|
For Additional Information Contact |
Kathleen Jaker 714-961-3666
|
Manufacturer Reason for Recall |
Package insert contains inaccurate information.
|
FDA Determined Cause 2 |
Other |
Quantity in Commerce |
233 |
Distribution |
United States and Canada |
Total Product Life Cycle |
TPLC Device Report
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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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