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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Customers using a randox rx imola instrument only will not be able use randox aldolase reagent (ad189) with the instrument specific application provided. the parameters shown on the screen shots on the instrument specific application sheet for aldolase assay on the rx imola instrument are incorrect. the settings do not allow for absorbance change therefore calibration is not possible and the assay cannot be run as a test. affected customers will receive an updated instrument specific application sheet for aldolase with the correct parameters.