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 initiated this recall notification due to a software anomaly in which under very specific circumstances the temperature in the well wash module of the vitros 3600 immunodiagnostic system and vitros 5600 integrated system may be out of range without alerting the operator.