Dako North America recalls

Dako North America appears in 8 official U.S. recall notices indexed by RecallRadar, most recently on 2018-07-18.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment options
  FDA Device · Class II · 2018-07-18 · Dako North America
• Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use
  FDA Device · Class II · 2016-07-06 · Dako North America
• EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mouse, High pH (Link) En…
  FDA Device · Class II · 2015-11-11 · Dako North America
• Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide stainer for in vitro di…
  FDA Device · Class II · 2015-05-06 · Dako North America
• Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800)
  FDA Device · Class II · 2015-03-18 · Dako North America
• Dako Autostainer Link 48 with software version Dako Link 4.0.3, Model No. AS480 Product Usage: For in vitro diagnostic use
  FDA Device · Class II · 2014-10-01 · Dako North America
• Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 20000910 Product Usage: For in vitro diagnostic use
  FDA Device · Class II · 2014-03-05 · Dako North America
• PT Link Waterbath, Model#PT100
  FDA Device · Class II · 2012-11-21 · Dako North America