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 centrifuge module on the power processor sample processing system exceeds the published acoustic noise specification of 74 decibels. beckman coulter iimplemented a new centrifuge motor on the power processor which included an additional cooling fan mounted directly on the motor shaft that spins when the centrifuge motor runs during centrifugation. as a result centrifuges with the new motor have two cooling fans that are positioned very close to each other and spin in opposite directions causing air turbulence and acoustic noise.