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
FDA Recall Z-0959-2008 · Posted 2008-04-30
Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeGKZ
Date Initiated2007-06-29
Date Terminated2012-12-13
Product Quantity516 units in the US; 73 units in Canada
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.
Firm 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.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution- USA and country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.