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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The manufacturer gen-probe gti diagnostics has recently received 2 complaints of decreases in the average optical density (od) of the positive control. this reduction in average od can cause the positive control values to be too low for a valid assay. since the decrease in positive control od lead to invalid assays the manufacturer has decided to voluntarily withdraw the affected lot from the market.