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 has confirmed reports of calibration failures on various advia centaur systems hiv ag/ab combo (chiv) kit lots due to imprecision of the low calibrator. an invalid calibration status will prevent chiv results from being generated. siemens has confirmed that due to sporadic aberrantly high relative light units (rlus) imprecision may be observed with the low calibrator negative quality control (qc) material or negative samples.