Recall Z-2708-2014
Dako North America Inc. · initiated August 29, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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 AS1030D0809 AS1032D0809 AS1072D0811 AS1185D0904 AS1186D0904 AS1187D0904 AS1418D0908 AS1220D0904 AS1292D0906 AS1354D0907 AS1472D0909 AS1473D0909 AS1556D1001 AS1817D1011 AS1904D1102 AS2036D1106 AS2353D1202 AS2357D1202 AS48-0273-01 AS48-0337-01 AS1266D0905 AS1624D1005 AS1695D1008…
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.
FDA-determined cause: Software change control
Action taken
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.
Details
- Recall number
- Z-2708-2014
- Initiated
- August 29, 2014
- Posted by FDA
- September 26, 2014
- Terminated
- March 3, 2015
- Product code
- KPA – Slide Stainer, Automated
- Quantity
- 191 units total (57 units in US)
- Distribution
- 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.
- Recalling firm
- Dako North America Inc., Carpinteria, CA