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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Reagents of specified lots failed qc requirements while within the assay stored calibration and onboard stability claims of 7 and 14 days respectively. this issue is detected through routine qc monitoring where results are out of the expected range values resulting in the failure of the tobramycin assay to meet the onboard stability claim.