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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Bd max system software version 4.44a contains a software anomaly that has the potential to affect some open system reagent (osr) customers utilizing user defined protocol (udp) assays. customers utilizing only ivd assays are not affected. this anomaly may cause osr customer system to incorrectly switch the columns of the truth table on the user's display. if the user tries to fix their display data the display will appear correct however the database may become incorrect potentially resulting in incorrect results reporting.