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 wash interconnect circuit board on the advia centaur/advia centaur xp can fail due to contamination on the board during manufacturing and/or during use. when a failure occurs it is possible to have incorrect reporting of the wash1 sensors status. the fluid line of either sensor (s1 or s2) is reported to be empty when it is actually full or reported to be full when it is empty. these failures could either lead to the system not detecting an empty wash1 bottle or reservoir or stop the system from running due to a supposedly empty wash1 reservoir. if the sensors both fail in the "wet" state due to the board malfunction an erroneous but believable result may be released to the physician which is falsely high or low (depending on the assay architecture - competitive or sandwich).