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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 February 13, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on May 08, 2012
Recall Number Z-0635-04
Recall Event ID 28379
Product Classification Counter, Cell, Automated (Particle Counter) - Product Code GKL
Product CXP software, Part No. 623560, version 1.0
Code Information Version 1.0
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92821-6208
For Additional Information Contact Kathleen Jaker
714-961-3666
Manufacturer Reason
for Recall		 Software anomaly. Sample ID and the Run Date may become fixed within a header on the FlowPAGE printout. All samples subsequently run, with results printed using the FlowPAGE print format, will have the fixed Sample ID and Run Date, rather than the correct Sample ID and Run Date.
FDA Determined
Cause 2		 Other
Action Firm sent modified operating instructions to users on 13 February 2004.
Quantity in Commerce 21
Distribution Nationwide 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.
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