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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An internal study has show that variance is introduced into the % hba1c result when the sample is run from the small sample container (ssc). previously (vc-14-03) cyclosporine was identified as under-recovering when run from the ssc. capa investigation has found that an unintentional dilution of the sample occurs when whole blood samples are transferred from the ssc to the aliquot well. %hba1c is a ration of two components. with the % hba1c the unintentional dilution of sample introduces variance into the final %hba1c result.