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Dako North America Inc.

6 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High p recall (Z-0220-2016)Dako North America Inc.2015-11-05
Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis S recall (Z-1548-2015)Dako North America Inc.2015-04-29
Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400) recall (Z-1261-2015)Dako North America Inc.2015-03-16
Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Us recall (Z-2708-2014)Dako North America Inc.2014-09-26
Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usag recall (Z-1093-2014)Dako North America Inc.2014-02-26
PT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarize recall (Z-0287-2013)Dako North America Inc.2012-11-13

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