BEUDAMED
    FDA Recall Terminated

    Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: For in vitro diagnostic use. The Dako Autostainer Link 48 is an automated slide processing system compatible with reagents for the staining of paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle aspirates. The system is designed to automate manual staining methods routinely used in immunohistochemistry and cytochemistry, enabling the transfer of established protocols from the bench to the Autostainer Link 48 automated workstations operating either singly or in networked configurations.

    Recall: Z-2708-2014 · Initiated August 29, 2014

    Recall

    Recall Number
    Z-2708-2014
    Event Number
    69191
    Firm
    Dako North America Inc.
    FEI Number
    2022180
    Product Code
    KPA
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    August 29, 2014
    Posted
    September 26, 2014
    Terminated
    March 3, 2015
    Address
    6392 Via Real, Carpinteria, CA, 93013-2921

    Description

    Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: For in vitro diagnostic use. The Dako Autostainer Link 48 is an automated slide processing system compatible with reagents for the staining of paraffin-embedded and frozen tissue sections, cytospins, cell smears and fine needle aspirates. The system is designed to automate manual staining methods routinely used in immunohistochemistry and cytochemistry, enabling the transfer of established protocols from the bench to the Autostainer Link 48 automated workstations operating either singly or in networked configurations.

    Reason

    Dako is recalling the Dako Link 4.0.3 software on the Dako Autostainer Link 48 because Dako has determined that an upgrade to this version of the software may cause premature rejection of reagent bottles or inadequate aspiration of reagent if the instrument has also had a preventative maintenance or waste pump replacement, and the baseplate is not completely aligned.

    Action

    Dako North America sent an Urgent Medical Device Correction letter to all customers who were upgraded to the Dako Link 4.0.3 software that is used on the Dako Autostainer Link 48 and who also had preventative maintenance or a waste pump replacement. The letter informs the customers of the problems identified and the actions to be taken. Customers are instructed that Dako will contact customers to set up an appointment for a service visit in order to ensure that the instruments are running safely or reliably. Customers with questions are instructed to contact Dako.

    Distribution

    Worldwide Distribution - US Nationwide in the states of AT, AU, BE, CA, CN, DE, DK, ES, Fl, FR, GB, IE, IT, NL, NO, SE, US, DZ, GR, IS, OM, SG, UY.

    Quantity

    191 units total (57 units in US)