BEUDAMED
    FDA Recall Terminated

    Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDX Software

    Recall: Z-0853-06 · Initiated April 26, 2005

    Recall

    Recall Number
    Z-0853-06
    Event Number
    35175
    Firm
    Affymetrix, Inc.
    FEI Number
    3003314809
    Product Code
    NSU
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 26, 2005
    Posted
    May 6, 2006
    Terminated
    December 13, 2006
    Address
    4G Crosby Dr, Bedford, MA, 01730-1402

    Description

    Affymetrix GeneChip Microarray Instrumentation System, consisting of GeneChip 3000Dx scanner with autoloader, FS450Dx fluidics station and GCOSDX Software

    Reason

    Incorrect software version of instrument controller is not compatible with new configuration. This incorrect configuration may cause the instrument system to fail at start-up or during a run.

    Action

    Afffymetrix notified the two hospitals by email dated 4/14/05 and by letter to the Distributor on 4/28/05. Affymetrix service personnel will be provided with discs to perform the software update. All field changes will be documented via Service Work Orders.

    Distribution

    California and Indiana Foreign: The Netherlands, Switzerland

    Quantity

    13 units