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.
데이터 추가 비고
원인
Ortho clinical diagnostics (ocd) was notified by its supplier that lot 1630 of calibration kit 16 would not meet its specified 12-month stability. ocd testing indicates that patient results generated using vitros chemistry products rf reagent calibrated with vitros calibrator kit 16 lot 1630 may demonstrate a positive bias across the measuring range of 8.6-120 iu/ml if a new calibration is performed. the positive bias is readily identifiable by routine post-calibration quality control testing with control fluids. to date ocd has not received any complaints related to this issue.