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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Siemens has identified an accelerated decline in counts per second (cps) for specific kit lots of the immulite/immulite 1000 systems third generation tsh assay (lkts1/5). this may lead to adjustment slopes greater than 1.8 before the expiration date indicated on the kit label is reached. if the adjustment slopes are elevated and qc results are within the established ranges reported patient results are acceptable.