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U.S. Department of Health and Human Services

Class 3 Device Recall

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  Class 3 Device Recall see related information
Date Initiated by Firm May 05, 2005
Date Posted August 13, 2005
Recall Status1 Terminated 3 on March 07, 2012
Recall Number Z-1369-05
Recall Event ID 32029
Product Classification Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use - Product Code LXG
Product Power Processor 3060 Tube Refrigerated Stockyard, P/N 6915556.
Code Information Various.
Recalling Firm/
Manufacturer
Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact Nancy E. Johnson
714-961-4489
Manufacturer Reason
for Recall
Device does not maintain a uniform internal temperature within 2-8 C at warmer ambient temperatures.
FDA Determined
Cause 2
Process change control
Action Recall letters mailed 5/5/2005 request users monitor the temperature variances and evaluate for continued use in thier laboratory.
Quantity in Commerce 46
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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