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
Follow-up to recall 64398. beckman coulter has confirmed customer reports of qc shifts lot-to-lot variation and an increase in the precent of patient samples recovering >20 iu/ml using lots m012376 and m101865 of immage rheumatoid factor (rf) reagent. these lots of rf might produce false abnormal results.