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 (ortho) has initiated this recall due to the potential for positively biased results generated when using vitros dtibc reagent gen 30. ortho determined that there are incorrect values (data/calibration mathematics) on assay data diskettes (add) for vitros calibrator kit 29 that support vitros dtibc reagent gen 30. the incorrect values will cause a positive bias in sample results (i.E. patient samples proficiency fluids and quality control fluids).