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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Customer complaints indicate intermittent calibration failures due to max fit deviations when using digoxin reagents (smn 10327549) with therapeutic drug monitoring (tdm) calibrator lot 300645. in most cases customers were able to recalibrate the assay after repeat calibrations. if digoxin calibration does not pass on the advia chemistry system patient samples cannot be run or reported. there are only two current lots of tdm calibrators and both were evaluated for max fit deviations. this confirmed failure when using tdm calibrator lot 300645. the new tdm calibrator lot 324889 did not have any failed calibrations due to max fit deviations. the tdm calibrator is used only for the digoxin assay.