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U.S. Department of Health and Human Services

Class 3 Device Recall

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 Class 3 Device Recallsee related information
Date Initiated by FirmMarch 28, 2003
Date PostedMay 09, 2003
Recall Status1 Terminated 3 on October 14, 2003
Recall NumberZ-0805-03
Recall Event ID 26040
Product Classification Station, Pipetting And Diluting, For Clinical Use - Product Code JQW
ProductCOULTER 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/
Manufacturer		 Beckman Coulter Inc
200 South Kraemer Blvd W 337
Brea CA 92822
For Additional Information ContactLynn McBride
714-993-5321
Manufacturer Reason
for Recall		Software problem may cause the instrument to skip the probe-wash step before processing different reagents.
FDA Determined
Cause 2		Other
ActionThe firm sent notification letter and modified operating instructions by mail on March 28, 2003.
Quantity in Commerce91
DistributionUSA and Canada
Total Product Life CycleTPLC 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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