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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The analytical sensitivity statements in the advia centaur/xp and advia centaur cp ifus were based on one lot of reagent. siemens evaluated the current p24 analytical sensitivity with multiple lots to determine if the hiv ag/ab combo (chiv) assay is meeting the ifu statements. five out of the seven lots evaluated on the advia centaur/xp and four out of seven lots evaluated on the advia centaur cp did not meet the statement in the ifu with regard to p24 analytical sensitivity. however the chiv assay is meeting the design requirements (dir target < 1.5 iu/ml dir minimum < 2.0 iu/ml) and the cts analytical sensitivity requirement of