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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Ortho clinical diagnostics has received customer complaints regarding intermittent invalid plates due to elevated optical densities (od) for the negative calibrator when using ortho htlv-i/ii ab-capture elisa test system lot htv208. a negative calibrator od that is outside the package insert specification would cause an invalid plate. if this occurs the entire plate is aborted and no results are reported.