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
The foil pouches for some ebv-na (en100) substrate slides appear to have been damaged resulting in exposure to moisture and a decrease in slide reactivity/loss of fluorescence. meridian's investigation has also determined that the desiccant packaged with the compromised ebv-na substrate slides have turned pink indicating exposure to moisture. the desiccants are typically blue.