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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Some customers may see an increase in calibration factor for urea nitrogen reagent osr6134 and osr6234 on the au480/au680 analyzers which in turn may lead to calibration failures that could delay quality control or patient sample analysis.