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 an inability to calibrate vitros chemistry products hba1c reagent kit generation (gen) 06 when using: vitros calibrator kit 31 lot 3155 and specific assay data diskettes ortho determined that there is an incorrect value (data/calibration mathematics) on adds (drv 5873 5874 5875 and 5876) for vitros calibrator kit 31 lot 3155 used to support vitros hba1c reagent kit gen 06. the incorrect value will prevent a successful calibration of the assay.