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
Siemens healthcare diagnostics has observed that the immulite systems rubella quantitative igg calibration verification material level cvm4 (lrubcvm4) is recovering high outside of the published instructions for use (ifu) guideline. the maximum individual replicate observed internally by siemens for lrubcvm4 using lot 0101 and 0102 was 687 iu/ml which is above the provided ifu guideline range of 352 - 528 iu/ml.