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 healthcare diagnostics received customer complaints regarding dimension lip flex reagent df55a. ten lots of lip are exhibiting open well instability. the qc is in range on calibration but shifts high out of range 2 hours after the flex well is hydrated. shifts of up to 20% occur on both qc and patients.