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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During the card loading process the sealer card pusher assembly could inadvertently make contact and move a cassette up to three card slots when the vacuum chamber is lowered which then causes the cassette to be out of alignment with the carousel incubator. as a result of this misalignment cards may be loaded into the carousel incubator in the wrong order resulting in mismatched results incorrect results or a delay in treatment due to the need to set up new cards.