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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Testing has shown that samples with grossly elevated ldh activity (greater than 30 times the upper limit of the reference range) when tested with the worst affected reagents can be falsely elevated by up to 25 mmol/l. this can also cause a slight positive bias in recovery (~ 2 mmol/l) of bicarbonate when the system is calibrated with aqueous calibrators and qc samples or normal patients' samples are run.