Dako North America Inc. recalls

5 recalls on record · latest: February 2, 2018

Official U.S. recall history for Dako North America Inc., compiled from official government records.

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Dako North America Inc. recalls PD-L1 IHC 22C3 pharmDx is a companion diagnostic used to determine PD-L1 levels for determination of patient treatment…

February 2, 2018 · Medical device recalls Moderate risk To correct the kit's instructions for use as the storage time for gastric and g…

Dako North America Inc. recalls Dako HER2 CISH pharmDx Kit, product code: SK 109 Product Usage: For in vitro diagnostic use. HER2 CISH pharmDx Kit is…

June 10, 2016 · Medical device recalls Moderate risk An incorrect HER2 probe concentration was used when producing the probe compone…

Dako North America Inc. recalls EnVision FLEX/HRP visualization reagent found in the following kits: EnVision FLEX, High pH (Link) EnVision FLEX+, Mous…

September 4, 2015 · Medical device recalls Moderate risk There is a defect in one lot of a buffer, non-specific background staining that…

Dako North America Inc. recalls Test Request Distributor (TRD 1.3 and TRD 1.4), a software module used on the Dako Omnis System, an automated slide sta…

April 1, 2015 · Medical device recalls Moderate risk If a user requests slides from the LIS or TPID, then updates a request by chang…

Dako North America Inc. recalls Autostainer Link 48 (AS480), Autostainer Plus Link Instrument (AS100), Autostainer (S3400), and Autostainer Plus (S3800…

February 12, 2015 · Medical device recalls Moderate risk A false negative result affecting the diagnosis may occur. A defect in the syri…