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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 March 28, 2003
Date Posted May 09, 2003
Recall Status1 Terminated 3 on October 14, 2003
Recall Number Z-0805-03
Recall Event ID 26040
Product Classification Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
Product COULTER PrepPlus and PrepPlus 2, Pipetting and Diluting station for Clinical Use
Code Information All existing versions of the software.   Serial numbers PrepPlus 0006026440 and above PrepPlus 2 0109079674 and above
Recalling Firm/
Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
For Additional Information Contact Lynn McBride
Manufacturer Reason
for Recall
Software problem may cause the instrument to skip the probe-wash step before processing different reagents.
FDA Determined
Cause 2
Action The firm sent notification letter and modified operating instructions by mail on March 28, 2003.
Quantity in Commerce 91
Distribution USA 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.