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
Quality control (qc) is shifting higher impacting direct bilirubin (dbil_2) with siemens chemistry calibrator lots 090445b and 090445c from previous lots 090445 and 090445a. observed qc shifts are ~7-9% higher with calibrator lots 090445b and 090445c. an urgent field safety notice has been issued by the manufacturer to provide affected customers with reassigned system specific values for the dbil_2 ssvs for chemistry calibrator lot numbers 090445b and 090445c. manufacturer has determined that the dbil_2 ssvs currently assigned to these lots may cause an average shift of +7-9% in quality control and sample recovery at a level of 3 mg/dl. the urgent field safety notice provides reassigned values for the dbil_2 ssvs for chemistry calibrator lot numbers 090445b and 090445c.