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 online tdm gentamicin assays may generate falsely elevated control and patient results when used with the current lot of preciset tdm 1 calibrator on the roche/hitachi analyzers.
Model Catalog: 03800504190 (Lot serial: All current lots); Model Catalog: 03800504190 (Lot serial: >10 contact mfg); Model Catalog: 04490843190 (Lot serial: All current lots); Model Catalog: 04490843190 (Lot serial: >10 contact mfg)