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 falsely negative results for voges-proskauer (vp) (pale-pink/brown/colorless) with quality control (qc) american type culture collection (atcc) organism staphylococcus aureus atcc 29213 in the affected panels. the expected result is positive. the falsely negative result was traced to a single vp componenet lot used in the manufacturing of the affected panels.