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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This recall is related to a potential reduction in the signal of the elecsys cmv igm assay when used in combination with some specific lots of diluent universal which may lead to false negative results for patients samples with high reactivity against one specific antigen included in the assay. therefore patient samples having also a high reactivity against this specific antigen may be affected by reduced cut-off values which may lead to a false negative result when the affected combination is used. the signal reduction has only minor effects on the calibrators and controls.