Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.1 and 2.2 - CXP analysis SW V2.1, 10 network user with Romlock, Automated differential cell counter; Part Number 722594; Beckman Coulter; Miami, FL 33196.
FDA Recall Z-2024-2008 · Posted 2008-07-11
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Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeGKZ
Date Initiated2007-05-04
Date Terminated2011-07-11
Product Quantity445 units in the US; 56 units in Canada
Reason for Recall
Incorrect Display: In certain modes, the protocol will not initially display the correct data in some plots. In addition, when running EWL files, any edited SampleID1 is not automatically updated in all tubes in the panel.
Firm Action
Consignees were notified of this safety recall by an Urgent Product Corrective Action letter sent on 5/3/07. The letter provided instructions on how to ensure correct data acquisition. Users were requested to return a response form acknowledging receipt of the letter. For additional information contact 1-800-526-7694.
Root Cause
Software design
Distribution Pattern
Worldwide Distribution including USA and country of Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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