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. (ocd) initiated this recall due to the potential for an increase in u90-382 or 6lu condition codes (wash errors) when using vitros calibrator kit 9 lot 0954. when a u90-382 or 6lu condition code occurs the vitros system suppresses the result and no result is reported. the increase in condition codes primarily occurs when using vitros dgxn and phyt slides. all numerical results obtained are valid providing that no wash errors occurred and quality control results were within acceptable limits.