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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Iris international has become aware of loose or missing analyte pads being found in several locations (strip vial stip provider module stip conveyor system or waste container) that are undetectable by the ichem velocity system. if affected strips are used to assay patient samples the issue has the potential to cause erroneous ph results and false negative results for the following tests: nitrite glucose blood bilirubin urobilinogen protein leukocyte esterase ketones and ascorbic acid.