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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 FirmAugust 02, 2004
Date PostedNovember 30, 2004
Recall Status1 Terminated 3 on May 08, 2012
Recall NumberZ-0259-05
Recall Event ID 29731
Product Classification Counter, Differential Cell - Product Code GKZ
ProductCXP Software Version 1.0 and 1.1 (operating software for Cytomics FD500 Cytometer. Part numbers: 624281, 623560, 623563, 623554, 623555, 623541, 623556, 623557, 623558, 623559.
Code Information Versions 1.0 and 1.1 Serial and lot numbers are not applicable.
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information ContactKathleen M. Jaker
714-961-3666
Manufacturer Reason
for Recall		Software anomaly.
FDA Determined
Cause 2		Other
ActionA recall letter and workaround solution were mailed August 2, 2004. Firm will initiate a software upgrade as well.
Quantity in Commerce89
DistributionNationwide 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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