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Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage:...

FDA Device Recall #Z-2708-2014 — Class II — August 29, 2014

Recall Summary

Recall Number Z-2708-2014
Classification Class II — Moderate risk
Date Initiated August 29, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Dako North America Inc.
Location Carpinteria, CA
Product Type Devices
Quantity 191 units total (57 units in US)

Product Description

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.

Distribution Pattern

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.

Lot / Code Information

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 AS1560D1001 AS1603D1004 AS1636D1005 AS1941D1103 AS2230D1110 AS2234D1110 AS2235D1110 AS2236D1110 AS2308D1111 AS2542D1207 AS1342D0907 AS1446D0909 AS48-0114-01 AS1293D0906 AS2110D1108 AS1161D0903 AS1162D0903 AS1427D0909 AS2147D1109 AS2148D1109 AS2418D1204 AS1431D0909 AS1014D0809 AS1093D0901 AS1190D0904 AS1210D0904 AS48-0309-01 AS48-0310-01 AS48-0317-01 AS48-0318-01 AS48-0326-01 AS1052D0811 AS1094D0901 AS1109D0902 AS1123D0903 AS1127D0903 AS1138D0903 AS1140D0903 AS1238D0904 AS1239D0904 AS1240D0905 AS1301D0906 AS1320D0906 AS1322D0906 AS1331D0907 AS1332D0907 AS1376D0907 AS1508D0910 AS1520D0910 AS1528D0911 AS1551D1001 AS1637D1006 AS1663D1007 AS1681D1007 AS1682D1007 AS1712D1008 AS1732D1009 AS1749D1009 AS1765D1010 AS1775D1010 AS1778D1010 AS1800D1010 AS1837D1011 AS1839D1011 AS1848D1011 AS1850D1011 AS1855D1011 AS1866D1012 AS1867D1012 AS1880D1101 AS1975D1104 AS1993D1105 AS2030D1106 AS2055D1106 AS48-0150-01 AS48-0152-01 AS48-0156-01 AS48-0166-01 AS48-0167-01 AS48-0177-01 AS48-0192-01 AS48-0205-01 AS48-0207-01 AS48-0213-01 AS48-0248-01 AS48-0259-01 AS48-0296-01 AS48-0315-01 AS2761D1301 AS48-0129-01 AS2169D1109 AS1820D1011 AS1584D1003 AS2014D1105

Other Recalls from Dako North America Inc.

Recall # Classification Product Date
Z-2425-2018 Class II PD-L1 IHC 22C3 pharmDx is a companion diagnosti... Feb 2, 2018
Z-2099-2016 Class II Dako HER2 CISH pharmDx Kit, product code: SK 10... Jun 10, 2016
Z-0220-2016 Class II EnVision FLEX/HRP visualization reagent found i... Sep 4, 2015
Z-1548-2015 Class II Test Request Distributor (TRD 1.3 and TRD 1.4),... Apr 1, 2015
Z-1261-2015 Class II Autostainer Link 48 (AS480), Autostainer Plus L... Feb 12, 2015

Frequently Asked Questions

A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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