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U.S. Department of Health and Human Services

Class 2 Device Recall FC 500 120V

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 Class 2 Device Recall FC 500 120Vsee related information
Date Initiated by FirmMay 04, 2007
Date PostedJuly 11, 2008
Recall Status1 Terminated 3 on July 11, 2011
Recall NumberZ-2017-2008
Recall Event ID 46287
Product Classification Automated differential cell counter - Product Code GKZ
ProductCytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - FC 500 120V, Automated differential cell counter; Part Number 6605628; Beckman Coulter; Miami, FL 33196.
Code Information Part Number 6605628
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		Incorrect Display: In certain modes, the protocol will not initially display the correct data in some plots. In addition, when running EWL files, any edited SampleID1 is not automatically updated in all tubes in the panel.
FDA Determined
Cause 2		Software design
ActionConsignees were notified of this safety recall by an Urgent Product Corrective Action letter sent on 5/3/07. The letter provided instructions on how to ensure correct data acquisition. Users were requested to return a response form acknowledging receipt of the letter. For additional information contact 1-800-526-7694.
Quantity in Commerce445 units in the US; 56 units in Canada
DistributionWorldwide Distribution including USA and country of 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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