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 of an inability to obtain a valid calibration when using vitros afp reagent packs: - vitros immunodiagnostic products afp reagent pack lot 1440 - vitros immunodiagnostic products afp calibrators lot 1440 ortho confirmed that this lot exhibited an increase in reaction signal over time. initial testing indicates that the unexpected signal increase is related to a specific lot of raw material used in the manufacture of this lot. the affected lot of vitros afp reagent packs met all quality assurance specifications upon release.