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
May cause reduced v-lyte integrated multisensor on-board use life as demonstrated by increases in urine qc sodium results within 48 hours after installation of a new imt sensor. the qc results can be elevated approximately 10-20% which results in urine qc results rising out of acceptable qc ranges.