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 manufacturer biocare medical has recently advised of a performance issue with the betazoid dab buffer (catalogue # ds900l lot 081913) contained within the mach 4 universal hrp-polymer detection kit (catalogue # bri4012l lot 090913). this recall has been initiated due to the staining performance of the kit. the failure is evident when processing control slides as a complete absence of staining by the chromogen. the root cause of this failure is an incorrect buffer was packaged in the kit.