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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There is a software issue that may affect results from diluted samples run on the vitros eci immunodiagnostic system tested with the vitros immunodiagnostics products total beta-hcg ii reagent pack. ocd has received complaints of observed results from diluted samples that were reported as <2.39 miu/ml (iu/l) instead of the correct 'no result' which is accompanied by an invalid dilution (id) code. the diluted results were inconsistent with results from the neat (undiluted) sample which was within the measuring range of 2.39-15000 miu/ml.