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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Beckman coulter has confirmed that kit lot 012781(vial lots: qc1:012778 qc2: 012779 and qc3: 012780) of access afp qc may contain a precipitate in all three qc levels included in the kit.