Reported Oct 1, 2014 · Terminated
Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: For in vitro diagnostic…
Dako North America Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dako North America Inc. · 6392 Via Real · Carpinteria, CA · 93013-2921
Is this the product you have?
- Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No
- AS480 Product UsageFor 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
- Lot codes and dates
- Serial Numbers
191 of 191 codes
AS1101D0902AS1722D1009AS2404D1203AS2710D1211AS1200D0904AS1298D0906AS1420D0908AS1606D1004AS1608D1004AS1610D1004AS1406D0908AS1498D0910AS1511D0910AS1542D1001AS1566D1002AS1684D1008AS1685D1008AS1708D1008AS1767D1010AS1779D1010AS1802D1010AS1865D1011AS2002D1105AS2039D1106AS2040D1106AS2041D1106AS2042D1106AS2044D1106AS2052D1106AS2057D1107AS2058D1107AS2071D1107AS2701D1211AS2707D1211AS48-0363-01AS1251D0905AS1149D0903AS1216D0904AS1270D0905AS1271D0905AS1311D0906AS1314D0906AS1356D0907AS1363D0907AS1691D1008AS1883D1101AS1934D1103AS2109D1108AS2111D1108AS2141D1108AS2158D1109AS2159D1109AS2170D1109AS2182D1109AS2192D1110AS2300D1111AS2358D1202AS2359D1202AS2361D1202AS2416D1204
- Serial Numbers
- Amount recalled
- 191 units total (57 units in US)
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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