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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The identified lot of spot-light her2 cish kit includes ssc buffer that may be contaminated with acremonium strictum a fungal contaminant. this incident was identified through a customer complaint. this customer also reported a weaker staining however in-house testing of the buffer with the kit indicated that the kit continues to perform as intended.