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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Bd has recently confirmed a manufacturing issue with the motor that drives movement of the robot arm. should this occur the instrument will indicate an e20 error and stop functioning. while there is no loss of patient sample the samples would need to be manually processed. bd a r?cemment confirm? un probl?me de fabrication avec le moteur qui anime le mouvement du bras du robot. si ce probl?me se manifeste l'instrument indiquera un code d'erreur e20 et cessera de fonctionner. tandis qu'il n'y a pas de perte d'?chantillons provenant des patients les ?chantillons devront ?tre trait?s manuellement.