Manufacturer
8 recalls in our database name Dako North America Inc. as the manufacturing or recalling firm.
Of the 8 recalls from Dako North America Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Dako North America Inc. is recalling 1,051 PD-L1 IHC 22C3 pharmDx kits to correct instructions for use regarding storage time for specific tissue sections.
Dako North America Inc. is recalling 31 kits of the HER2 CISH pharmDx Kit because the HER2 probe concentration was too low.
Dako North America Inc. is recalling specific lots of EnVision FLEX visualization reagent kits due to a buffer defect causing non-specific background staining that interferes with result interpretation.
Dako North America is recalling the Test Request Distributor software module for the Dako Omnis System because it may execute the wrong test after a user updates a request.
Dako North America Inc. is recalling four models of automated slide stainers because a defect may cause buffer leakage, leading to false negative diagnostic results.
Dako is recalling software for the Autostainer Link 48 because an upgrade may cause premature reagent rejection or inadequate aspiration if specific maintenance conditions are met.
Dako North America Inc. is recalling 49 units of the HER2 CISH pharmDx Kit because weak red signals have been observed.
Dako North America Inc. is recalling 136 PT Link Waterbath units due to a potential electrical shock hazard if the heater pad becomes wet.