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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Bact/alert pf plus culture bottle lot 1033237 yielded reflectance results above the stability specification at the 9 month timeframe. bottles that have reflectance results near or greater than the initial value threshold specification when first loaded on the instrument could have an increased probability of false positive results.