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U.S. Department of Health and Human Services

Class 2 Device Recall CXP analysis SW V2.1, 10 network user with Romlock

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  Class 2 Device Recall CXP analysis SW V2.1, 10 network user with Romlock see related information
Date Initiated by Firm May 04, 2007
Date Posted July 11, 2008
Recall Status1 Terminated 3 on July 11, 2011
Recall Number Z-2024-2008
Recall Event ID 46287
Product Classification Automated differential cell counter - Product Code GKZ
Product Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 10 network user with Romlock, Automated differential cell counter; Part Number 722594; Beckman Coulter; Miami, FL 33196.
Code Information Part Number 722594
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact Nora 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
Action Consignees 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 Commerce 445 units in the US; 56 units in Canada
Distribution Worldwide Distribution including USA and country of Canada.
Total Product Life Cycle TPLC 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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