Dako Autostainer Link 48 with software version Dako Link 4 — Class II medical device recall Z-2708-2014
Terminated recall by Dako North America Inc., reported 2014-10-01, distributed nationwide. Dako is recalling the Dako Link 4.0.3 software on the Dako Autostainer Link 48 because Dako has determined tha
| Recall number | Z-2708-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dako North America Inc., Carpinteria, CA, United States |
| Recall initiated | 2014-08-29 |
| Classified | 2014-09-25 |
| Reported by FDA | 2014-10-01 |
| Terminated | 2015-03-03 |
| Distributed | Nationwide (US) |
| Reason classes | software |
| Serial numbers | AS1014D0809, AS1025D0809, AS1027D0809, AS1029D0809, AS1030D0809, AS1032D0809, AS1052D0811, AS1072D0811, AS1093D0901, AS1094D0901, AS1101D0902, AS1109D0902, AS1123D0903, AS1127D0903, AS1138D0903, AS1140D0903, AS1149D0903, AS1161D0903, AS1162D0903, AS1185D0904, AS1186D0904, AS1187D0904, AS1190D0904, AS1200D0904, AS1210D0904 and 166 more |
| Model numbers | AS480 |
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 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 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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.