FDA Device recall Z-2708-2014
Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: For in vitro diagnostic use
- FDA Device
- Class II
- terminated
- Published 2014-10-01
On 2014-10-01 the FDA classified a Class II recall of Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: For in vitro diagnostic use by Dako North America, citing 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 reje….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2708-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-08-29 |
| Published | 2014-10-01 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Dako North America |
| Distribution | US |
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
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.
Identifiers
| code_info | Serial Numbers: AS1101D0902 AS1722D1009 AS2404D1203 AS2710D1211 AS1200D0904 AS1298D0906 AS1420D0908 AS1606D10…Serial Numbers: AS1101D0902 AS1722D1009 AS2404D1203 AS2710D1211 AS1200D0904 AS1298D0906 AS1420D0908 AS1606D1004 AS1608D1004 AS1610D1004 AS1406D0908 AS1498D0910 AS1511D0910 AS1542D1001 AS1566D1002 AS1684D1008 AS1685D1008 AS1708D1008 AS1767D1010 AS1779D1010 AS1802D1010 AS1865D1011 AS2002D1105 AS2039D1106 AS2040D1106 AS2041D1106 AS2042D1106 AS2044D1106 AS2052D1106 AS2057D1107 AS2058D1107 AS2071D1107 AS2701D1211 AS2707D1211 AS48-0363-01 AS1251D0905 AS1149D0903 AS1216D0904 AS1270D0905 AS1271D0905 AS1311D0906 AS1314D0906 AS1356D0907 AS1363D0907 AS1691D1008 AS1883D1101 AS1934D1103 AS2109D1108 AS2111D1108 AS2141D1108 AS2158D1109 AS2159D1109 AS2170D1109 AS2182D1109 AS2192D1110 AS2300D1111 AS2358D1202 AS2359D1202 AS2361D1202 AS2416D1204 AS2504D1206 AS2516D1206 AS2678D1210 AS48-0196-01 AS48-0233-01 AS48-0234-01 AS48-0236-01 AS48-0237-01 AS48-0306-01 AS48-0332-01 AS48-0344-01 AS1025D0809 AS1027D0809 AS1029D0809 AS1030D080 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2708-2014%22
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