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 for higher than expected signal/cutoff (s/c) results outside the control's expected range when using vitros hbsag controls (the negative control). the positive shift in results occurs prior to the 5 day opened-reconstituted stability product claim for vitros hbsag controls lots 0860 0870 0880 0890 and 0908. a positive shift with the positive control may also be observed but the shift is within the control's expected range.