Dako Autostainer Link 48 with software version Dako Link 4.0.3
Medical device recall Z-2708-2014. Published in FDA’s Enforcement Report on Oct 1, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 1, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 191 units total (57 units in US) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
191 units total (57 units in US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: AS1101D0902 AS1722D1009 AS2404D1203 AS2710D1211 AS1200D0904 AS1298D0906 AS1420D0908 AS1606D1004 AS1608D1004 AS1610D1004 AS1406D0908 AS1498D0910 AS1511D0910 AS1542D1001 AS1566D1002 AS1684D1008 AS1685D1008 AS1708D1008…
Every code shown here, 1,989 characters
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…
FDA’s list runs to 2,339 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
- California
- Delaware
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 29, 2014.
- FDA classified it on Sep 25, 2014.
- FDA’s Enforcement Report published it on Oct 1, 2014.
- FDA terminated it on Mar 3, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Dako North America Inc., of Carpinteria, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,339 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.