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 identified that the coulter body fluid control level 1 vial (lot numebr 1803019890) packaged into final product kit (part number 628030 lot number 3029080k) may have been packaged with defective vial caps. this defect may result in a leak of the vial contents resulting in a situation where there is a potential for exposure to biohazardous material.