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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Multiple customer complaints were received reporting hba1c bias on patient samples and for cap survey failures when using a1c_3 calibrator lots 3hd044 3ld068. siemens has confirmed a -9% to -11% bias on these calibrator lots. the quality control values although high biased recover within assigned ranges - therefore may not detect the issue. an internal complaint was also generated for ngsp certification failure due to a low bias.