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

• Date Initiated by Firm: June 29, 2007
• Date Posted: April 30, 2008
• Recall Status: Terminated 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: 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