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 inc. (ortho) initiated this urgent product correction notification due to the need to clarify operator actions following u90-382 or 6lu condition codes generated by the systems affected by this recall. u90-382 or 6lu condition codes are associated with wash errors that may occur when using vitros chemistry products for immunorate assays (i.E. vitros crbm crp dgxn and phyt slides). if a u90-382 or 6lu condition code (i.E. associated with a wash error) occurs the condition code text located on the vitros system and other user documentation indicates to dilute the sample. however dilution may not be the appropriate action for all scenarios.