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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Anomalous decrease in the average optical density (od) results. during internal testing the average od values for the positive control were lower than expected in these lots. in most cases the lower reactivity led to invalid assay runs. in a few instances the assays were condisered valid but due to the lower than expected reactivity the sensitivity may have been decreased for samples with average od values near the assay cutoff.