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 has initiated this recall due to the potential to obtain lower than expected quality control (qc) results for vitros benz reagent using specific lots of vitros dat performance verifiers. if the issue occurs qc results for benz may be at or below ortho's range of means as defined in the assay sheets. this issue may lead to an inability to verify calibration or cause failures in daily qc results.