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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Under certain conditions when an engen laboratory automation system (engen system) is configured with a recapper module there is a potential for recapper caps for use with the recapper module to fall off of or be knocked from sample tubes placed in the storage racks of entry/exit modules. there is also the possibility for the gripper to grab a tube at the wrong height and drop the tube in the rack entry/exit or rack exit module. these situations may result in splashing of bio-hazardous fluid and sample cross-contamination may occur if there is an uncapped tube in the rack.