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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Upon investigation into complaints from customers helena laboratories has confirmed that control values for this lot of gel alkaline phosphatase isoenzyme control have fallen outside the acceptable range. when control values fall outside of the acceptable range the run is considered invalid. results from an invalid run cannot be reported and the run needs to be repeated.