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 to communicate the installation of an update to the weak d assay on the neo instrument. this update has been developed to resolve potential invalid results generated when the negative control well (well c1) reacts unexpectedly strongly positive due to droplet accumulation.