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 current lot #155166 of tg gen.2 (thyroglobulin) assay shows a premature ageing effect which leads to a positive bias of approximately 1ng/ml tg when used in combination with all current lots # 151605 152737 155488 and 157297 of elecsys thyroglobulin calibrator. the manufacturer has determined that customers should not use it for this purpose anymore.