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 determined that immage cuvette sectors (p/n 470706) may be missing one of two positioning pins. cuvette sectors missing a positioning pin can become misaligned. if a cuvette sector becomes misaligned under rare circumstances the instrument mixer paddle may rub against the inside wall of the cuvette and create a noise.