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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Blood bag cups (pn: 363651) designed for the js-4.2sm (pn348394) and js-4.2sma rotors (pn366670) that are damaged may break during centrifugation potentially releasing biohazardous material into the chamber of the centrifuge.