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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Manufacturer has confirmed intermittent aliquot plate barcode failure to read errors causing the plate to be discarded. the error is generated when the aliquot plate is being loaded onboard the instrument or recalled from the aliquot elevator for an add-on test. if the aliquot plate cannot be read it is discarded into the waste. not all plates within a lot exhibit the failure. not all instruments experience failures with the same lot of aliquot plates.