Dako Autostainer Link 48 Software Recall for Reagent Handling Issues
Dako is recalling software for the Autostainer Link 48 because an upgrade may cause premature reagent rejection or inadequate aspiration if specific maintenance conditions are met.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential diagnostic errors due to reagent handling issues, which is a moderate risk without reported injuries or fatalities.
Plain-English summary
Dako North America Inc. is recalling the Dako Link 4.0.3 software installed on the Dako Autostainer Link 48 automated slide processing system. The recall involves 191 units total, with 57 units distributed in the United States. The product is used for in vitro diagnostic purposes, specifically for the staining of paraffin-embedded and frozen tissue sections, cytospins, cell smears, and fine needle aspirates.
The recall is being issued because Dako determined that an upgrade to this specific software version may cause premature rejection of reagent bottles or inadequate aspiration of reagent. This issue may occur if the instrument has also undergone preventative maintenance or a waste pump replacement and the baseplate is not completely aligned.
The affected units are distributed worldwide, including in the United States, Canada, and various European and Asian countries. Users of the Dako Autostainer Link 48 should check their software version and consult Dako for instructions on how to resolve the issue.
The recalled product
- Product
- 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 se
- Manufacturer
- Dako North America Inc.
Distribution
Distributed nationwide across the United States.
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