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 used dilution wells to be reused. reuse of dilution wells can occur if: - an ocd field engineer performs a clean-up of the analyzer database or if an operator restores a database backup on the analyzer and - dilution trays have not been removed from the instrument prior to restarting the system. in this situation the analyzer software cannot identify usage history of the dilution wells on the instrument and reuse of wells may occur.