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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Following additional quality controls with a parameter (1 ml specimen/bk virus) which mimic the worst case condition a drift of the extraction performances was detected. this drift/decrease of performance after nuclisens easymag nuclisens minimag and emag extraction induced a difference superior to -05 log quantification on amplification assays on dna. this difference superior to -05 log is significant on results. as the downstream applications are qualitative and/or quantitative methods if the customer does not detect the issue the decrease of downstream application performance could lead to : 1. a risk of false negative for qualitative tests 2. invalid results when the internal amplification control is not on specifications. 3. under quantified results for quantitative tests.