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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 FirmNovember 02, 2004
Date PostedNovember 30, 2004
Recall Status1 Terminated 3 on May 08, 2012
Recall NumberZ-0266-05
Recall Event ID 30424
Product Classification Counter, Differential Cell - Product Code GKZ
ProductCXP software for Cytomics FC500 Cytometer
Code Information Versions 1.0, 1.1, and 2.0
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information ContactKathleen Jaker
714-961-3666
Manufacturer Reason
for Recall		Incorrect sample identification can be displayed and printed on the Runtime Panel Report due to a software defect.
FDA Determined
Cause 2		Other
ActionThe Product Corrective Action Customer Letter which includes Modified Operating Instructions was sent to US and Canadian customers the week of November 8, 2004 via US Mail.
Quantity in Commerce167
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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