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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Siemens healthcare diagnostics has confirmed the emit ethosuximide assay (etho) reagent lot h1 fails to calibrate on the viva-e v-twin viva proe and au clinical chemistry systems (au analyzers) when tested with the emit antiepileptic drug (aed) calibrator lot h1. the calibration failure will not allow the user to accept and store the calibration. all other in date emit ethosuximide lots successfully pass calibration when tested with the emit aed calibrator lot h1.