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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Certain lots do not meet the thirty (30) day open vial adjustor stability claim when reconstituted and stored at 2-8 deg.C as published in the ifu. after a two week (14 days) period may show a bias in patient samples and may result in quality control falling outside of established ranges. identified lots can exhibit an average bias of 14.5% at day 21 to 16.5% at day 28 (for shbg conc. of 5nmol?l to 170nmol/l) during the open vial adjustor stability period of 30 days. the bias observed was not conc. dependent.