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) is issuing this recall due to an unlikely scenario in which a user inappropriately removes or interchanges samples in an onboard sample rack or removes an onboard dilution tray after making a reagents load/unload request. if an unexpected change is made in a load station location that was not selected via the graphical user interface (gui) the system will not detect the change. if users deviate from normal process for changing patient samples the analyzer may not detect the change. in this case samples can be associated with another sample id which can potentially lead to erroneous test results being reported. this issue was identified internally by ortho. to date ortho has received no customer complaints or reports of patient injury due to this issue.