510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-0959-2008

Cytomics FC 500 MPL Flow Cytometry System with CXP Software, Software Version 2.2, Automated differential...

Siemens Healthcare Diagnostics Inc. / initiated 2007-06-29 / Terminated / root cause: software
FDA source (opens on fda.gov)

Beckman Coulter Inc began a recall of Cytomics FC 500 MPL Flow Cytometry System with CXP Software, Software Version 2.2, Automated differential cell counter, Part Number 626553, Beckman Coulter... on . The reason FDA records is "Data generation error: If the cytosettings is not refreshed or restarted during data importation, the output will include old and new data". As of , the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number
Z-0959-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Siemens Healthcare Diagnostics Inc.
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
Product code
GKZ Counter, Differential Cell
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.
Root cause tag
software
FDA root 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.
Product codes and lots
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.