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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Beckman coulter has received a number of complaints concerning failed calibrations for specific lots of au bicarbonate reagent used on beckman coulter au analyzers. if calibration failures are generated using the specified lots of bicarbonate reagent this may cause a delay in generation and release of patient results. no erroneous results will be generated as a result of this failure.