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U.S. Department of Health and Human Services

Class 2 Device Recall Cytomics Flow Cytometry System

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 Class 2 Device Recall Cytomics Flow Cytometry Systemsee related information
Date Initiated by FirmJuly 26, 2006
Date PostedNovember 21, 2006
Recall Status1 Terminated 3 on February 29, 2012
Recall NumberZ-0197-2007
Recall Event ID 36397
510(K)NumberK030828 
Product Classification Flow Cytometry System - Product Code GKZ
ProductCytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1
Code Information Part Numbers: 722645 Software Kit; CXP version 2.1 New User; 723113 Software Kit; CXP version 2.1 Upgrade; 629637 Software Kit; CXP version 2.0 New User; 629636 Software Kit; CXP version 2.0 Upgrade; 626553 TN; FC500 WITH UPS; 6605627 TN; 5 CLR, FC500 (IOOV); 6605628 TN; 5 CLR, FC500 (120V); 6605629 TN; 5 CLR, FC500 (220V); 6605630 TN;5 CLR, FC500 (240V)
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		Mis-identification-If a panel or protocol is added to an existing worklist but the tube location is not specified, the CXP Acquisition software will run the last specified tube through the remaining protocols and will generate results and printouts of these runs leading to a Mis-Identification condition.
FDA Determined
Cause 2		Other
ActionCustomer letter -- A Product Corrective Action (PCA) letter was sent the week of July 24, 2006 to all accounts that have FC500 with CXP Software 2.0 and 2.1 to inform them that a potential sample misidentification may occur when running a Work list with missing tube Location(s) in Automatic MCL mode. The letter outlines actions to be taken to avoid mis-identification of patient results.
Quantity in Commerce416 (US) + 60 (Canada)
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.
510(K) Database510(K)s with Product Code = GKZ
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