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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An ir sensor module failure can occur and can be identified by one of the following: volume detection error message errid: 5694 timeout error message errid: 5405 system initialization failure of the conveyor belt module. immediately prior to the failure there is a remote possibility that the ir sensor module may not properly detect the sample volume in the tube. the ir sensor module is part of the tube inspection unit (tiu) and is responsible for sample volume detection on automate systems. failure to properly detect the sample volume in the tube may cause an increased number of primary and secondary sample tubes to be transferred to the error workplace on the automate system. as a result of the failure there may be unexpected downtime of the automate system.