Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Four customer complaints were received for one lot of ar176 artisan grocott's methenamine silver (gms) stain kit regarding fungal looking organisms appearing after staining particularly on the periphery of slides away from the stained tissue. the contaminate was confirmed to be fungal most likely common indoor mold wallemia sebi and was confined to one reagent supplied by an outside vendor. artisan grocott's methenamine silver (gms) stain kit is indicated for identifying fungal organisms including pneumocystis jirovecii. the contamination could potentially compromise the device's diagnostic effectiveness.