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 confirmed a negative shift of 5 mmol/l for sodium recovery in synchron control level 3 when calibrated with aqua cal 1 lot 72645074. a linearity study using maine linearity standards also indicated a negative shift of up to 8 mmol/l at values between 150 and 180 mmol/l.