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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.

FDA Recall Z-2708-2014 · Posted 2014-09-26

Recalling FirmDako North America Inc.
Recall StatusTerminated
Product CodeKPA
Date Initiated2014-08-29
Date Terminated2015-03-03
Product Quantity191 units total (57 units in US)

Reason for Recall

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.

Firm 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.

Root Cause

Software change control

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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