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U.S. Department of Health and Human Services

Class 2 Device Recall FC 500 with CXP Acquisition Software

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  Class 2 Device Recall FC 500 with CXP Acquisition Software see related information
Date Initiated by Firm August 01, 2007
Date Posted January 07, 2009
Recall Status1 Terminated 3 on January 13, 2009
Recall Number Z-0455-2009
Recall Event ID 49010
510(K)Number K030828  
Product Classification Automated Differential Cell Counter - Product Code GKZ
Product Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2
Code Information Part Numbers 626553, Version 2.2
Recalling Firm/
Manufacturer		 Beckman Coulter Inc
200 S Kraemer Blvd
Brea CA 92822-6208
For Additional Information Contact
714-993-5321 Ext. 8383
Manufacturer Reason
for Recall		 Software error: The recall was initiated after Beckman Coulter identified that the CXP User documentation does not adequately characterize the use of the Live Gate feature. The primary use of a Live Gate is for the international removal of unwanted events, such as debris. The data outside of the Live Gate will not be stored to the final listmode file, this reducing the data set size. The softwa
FDA Determined
Cause 2		 Software design
Action The customer notifications were initiated by Beckman Coulter on July 23, 2007 when a Product Corrective Action (PCA) was mailed via US Postal Service to all affected customers. The PCA informed the customers that the user documentation does not adequately characterize the use of the Live Gate feature. The letter provides the customer with explanation of Live Gate and actions to be taken. For further information, please contact Beckman Coulter, Inc. by telephone at 714-993-5321.
Quantity in Commerce 565
Distribution Globally to the United States and 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.
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