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 have received customer inquiries for qc and patient shifts following calibration with lot 1dd085. internal testing has confirmed shifts with some calibrator sets from this lot. operations has tested one set of 1dd085 from six shipments from the american distribution centre (adc) in indianapolis indiana to glasgow delaware and found two sets to recover within 3% of nominal two sets to recover 3-5% below nominal and two sets to recover 5-7% below nominal. calibrator sets recovering below nominal will cause qc and patients to shift high. a patient shift of up to 26% may occur at 0.04 ng/ml which could change a sample to 0.05 ng/ml which is above the 99th percentile upper reference interval (0.045 ng/ml).