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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원인
Beckman coulter has confirmed that the serial nameplate attached to rear of the affected devices does not include the nationally recognized testing laboratory (nrtl) certification graphic and therefore the affected devices do not meet the us and canadian occupational safety labeling requirements. this is a labeling error only as the safety of the product has been certified by the nrtl and otherwise meets the us and canadian occupational and safety requirements. the devices therefore are compliant with all ul/csa requirements and received the tuv certificates. the performance of the devices is not impacted.