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U.S. Department of Health and Human Services

Class 3 Device Recall Cytomics FC 500 Flow Cytometry System with CXP Software, Software Version 2.2

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  Class 3 Device Recall Cytomics FC 500 Flow Cytometry System with CXP Software, Software Version 2.2 see related information
Date Initiated by Firm June 29, 2007
Date Posted April 30, 2008
Recall Status1 Terminated 3 on December 13, 2012
Recall Number Z-0959-2008
Recall Event ID 45945
510(K)Number K030828  
Product Classification Automated differential cell counter - Product Code GKZ
Product Cytomics FC 500 MPL Flow Cytometry System with CXP Software, Software Version 2.2, Automated differential cell counter, Part Number 626553, Beckman Coulter, Fullerton, CA 92834
Code Information Serial Numbers: AL11058, AK20149, AJ37243, AJ08035, AK16130, AK01004, AJ33215, AK16129, AK25182, AK51355, AL13064, AJ38253, AK51353, AK07059, AL12062, AJ40271, AJ02008, AJ50371, AK07058, AL21134, AJ01002, AK12093, AL15085, AL14077, AJ30191, AJ48342, AK20152, AK07060, AJ37246, AJ06026, AK32539, AJ39259, AL04022, AJ37240, AK48336, AJ46318, AJ14074, AJ17095, AK34227, AJ47331, AJ48341, AJ33210, AK48347, AK20158, AK12095, AK16131, AK19146, AK17138, AJ25164, AJ24147, AJ51381, AJ48339, AK51359, AJ49351, AL14082, AL22140, AJ24155, AJ47332, AK51358, AL23144, AJ24151, AJ49348, AK51380, AJ38250, AK48343, AK17135, AK18141, AK09075, AK13103, AJ29184, AJ30189, AJ02006, AJ14075, AJ14073, AJ15079, AJ16087, AJ16085, AJ15078, AJ16083, AJ19103, AJ19111, AJ21116, AJ19109, AJ21114, AJ21115, AJ21117, AJ22121, AJ22122, AJ23135, AJ25165, AJ24156, AJ25159, AJ24154, AJ25167, AJ25161, AJ47327, AK07062, AK33215, AL18108, AL20125, AJ17091, AK34232, AJ25160, AJ25163, AK05025, AJ29181, AJ50366, AK48328, AJ44313, AK51370, AK34230, AJ38248, AL19111, AJ12063, AJ44309, AJ22124, AK08071, AK48334, AK25177, AJ48344, AJ42294, AK51372, AL12063, AJ24158, AJ46319, AJ43298, AK30199, AK20153, AK51354, AJ31195, AJ49349, AJ12064, AK33225, AJ35229, AK17140, AJ29183, AK16127, AJ36234, AK17134, AL09044, AJ48340, AK19147, AK39264, AL21133, AL06033, AJ19110, AJ10048, AK51361, AJ24148, AJ50368, AJ11056, AJ34221, AJ03012, AK19148, AK06051, AK34233, AK39246, AJ14072, AJ44316, AJ42292, AK48338, AK34229, AJ29182, AK18139, AK08066, AK44284, AJ05020, AK30204, AK08063, AJ34217, AJ23129, AJ23134, AJ34226, AJ37238, AK25181, AK34231, AK34228, AK34234, AK48342, AJ24142, AK39266, AJ47326, AL21135, AJ07032, AL16093, AJ38251, AJ38252, AJ43300, OAK48341, AJ23138, AJ25166, AL23145, AK39273, AJ30194, AK02009, AJ24144, AJ32209, AL13073.
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		 Data generation error: If the cytosettings is not refreshed or restarted during data importation, the output will include old and new data.
FDA Determined
Cause 2		 Software design
Action Consignees were notified by an Urgent Product Corrective Action letter sent on 6/29/07. The letter provided details on the data error and instruction on how to avoid the error. Users were asked to retain notification as part of the Quality Systems documentation and return a response form acknowledging receipt. For additional information, contact 1-800-526-7694.
Quantity in Commerce 516 units in the US; 73 units in Canada
Distribution Worldwide Distribution- 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.
510(K) Database 510(K)s with Product Code = GKZ and Original Applicant = BECKMAN COULTER, INC.
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