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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There have been reports of quality control (qc) shifts with pseudocholinesterase (pche) and imprecision during pche calibration with dimension vista enzyme 1 calibrator (enz 1 cal) lots 3fd034 and 3hd012. investigation by siemens confirms a loss of pche activity in the affected lots of enzyme 1 calibrator causing an elevation of qc by as much as 80% and in some instances imprecision of replicates during calibration.