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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Several complaints were received for invalid calibration with low calibrator s1 while using vidas lh. furthermore tests performed internally confirmed a decrease of the strips signal overtime for the lot 1006041540. the defect was highlighted with complaints for invalid calibration but concerns all tests performed (calibration and patient's samples testing). the investigation concluded that this could have an impact on patient's results.