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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Following the launch of the last software upgrade to neo install set 2.1 (aurora 2.09) there have been sporadic complaints in which results are not being received in the data management software (dms). users most commonly report that results are not visible in the results folder and/or do not print once processing is complete. when this occurs the user must intervene to try to resend the results to the dms or in many cases repeat the test. in this event the hazard is delay in reporting results. this issue has been linked to reuse of capture plate frames and users are advised to not use a plate frame more than 12 times.