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U.S. Department of Health and Human Services

Class 2 Device Recall Cytomics FC500 with CXP Software

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 Class 2 Device Recall Cytomics FC500 with CXP Softwaresee related information
Date Initiated by FirmNovember 23, 2005
Date PostedJanuary 11, 2006
Recall Status1 Terminated 3 on January 26, 2012
Recall NumberZ-0380-06
Recall Event ID 34247
Product Classification Analyzer, Chemistry, Micro, For Clinical Use - Product Code JJF
ProductCytomics FC500 with CXP Software
Code Information Part Numbers 629636 629637 
FEI Number 2050012
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information ContactNora Zerounian
714-961-3634
Manufacturer Reason
for Recall		Under certain conditions an incorrect Tube ID (Barcode) can be displayed and printed on the Runtime Panel Report in CXP Cytometer Software Version 2.0
FDA Determined
Cause 2		Software change control
ActionA Product Corrective Action letter will be mailed the week of Nov 28, 2005 to all FC500 wi CXP Software customers. Each user will be contacted initially and then once more (if needed) in order to determine the rate of response from the Response form provided.
Quantity in Commerce179
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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