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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Potential to report incorrect antimicrobial interpretations for extended-spectrum beta-lactamase (esbl)-producing organisms when the group level id feature for processing fluorogenic gram neg panels is enabled.
Model Catalog: B1017-110 (Lot serial: FLUOROGENIC GRAM NEGATIVE); Model Catalog: B1017-110 (Lot serial: PANEL WILL BE AFFECTED.); Model Catalog: B1017-110 (Lot serial: ONLY CUSTOMERS USING)