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U.S. Department of Health and Human Services

Class 2 Device Recall Cytomics FC 500 MPL

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  Class 2 Device Recall Cytomics FC 500 MPL see related information
Date Initiated by Firm August 29, 2006
Date Posted February 08, 2007
Recall Status1 Terminated 3 on April 19, 2012
Recall Number Z-0419-2007
Recall Event ID 37083
510(K)Number K030828  
Product Classification cell analyzer - Product Code GKZ
Product Cytomics FC 500 MPL with MXP software, Versions 2.0 & 2.1: Part #731419 KIT; FOC MXP 2.0 UPGRADE KIT; Part #731418 SWRE KIT; MXP 2.0 NEW USER; Part #772145 MXP 2.1 FOC Upgrade Kit; 771938 MXP 2.1 Software; Part #771952 FOC MXP 2.1 Upgrade Kit; Part #771953 New User MXP 2.1 Kit. The Cytomics FC 500 is a system for the qualitative and quantitative measurement of biological and physical properties of cells and other particles.
Code Information Part Numbers: 731419, 731418, 772145, 771938, 771952, 771953. Software, Versions 2.0 & 2.1
Recalling Firm/
Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact Nora Zerounian
Manufacturer Reason
for Recall
Two workflow scenarios associated with renaming regions may produce incorrect results.
FDA Determined
Cause 2
Action A Product Corrective Action (PCA) letter was sent on the week of August 29, 2006 to all accounts that have an FC500 or have ordered CXP or MXP software to inform them that a) incorrect statistics are generated when a polygonal region with vertical re-entrant vertices is renamed using the Region Properties dialog box. b)when a region is copied from one plot to another, and then the new region is renamed, the statistics are not updated with the new region name. (Letter was sent by US mail). Letter includes immediate user preventive action to remedy both issues. A response form is included for consignees to return to recalling firm.
Quantity in Commerce 26 units nationwide
Distribution Nationwide & 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.
510(K) Database 510(K)s with Product Code = GKZ and Original Applicant = BECKMAN COULTER, INC.