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 a rare potential issue with the tip present sensor within the robot of the aliquoter module. there has been one report of a misaligned sensor in an automate system which resulted in the system processing samples without pipette tips. a small number of samples were subject to cross-contamination and were sent to the error rack prior to analysis. in this particular case the system gave no external sign of a misaligned tip present sensor.