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
A technical suppot bulletin (tsb-190) provided instructions for creating new labpro ast interpretation action alert rules to enable reporting of the new enterobacteriaceae breakpoints on microscan dried gram negative mic/combo panel types containing the lower imipenem (imp) dilutions. however the tsb did not mention the performance limitation for the enterobacteria proteus mirabilis and imipenem for which the revised interpretive criteria may result in minor errors with clinical p. mirabilis isolates. therefore the drug name minimal inhibitory concentration (mic) and interpretation should not be reported for p. mirabilis and imp on the microscan dried gram negative mic/combo panels listed in (1).