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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The reason for the recall is related to potential increased recovery of patient results (approximately 15-20%) while using the online tdm gentamicin assay on roche cobas c311 c501/c502 c701/c702 or modular p platforms in combination with preciset tdm i of specific lots. this issue does not affect the gentamicin reagent used on the cobas integra systems.