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.
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Confirmation of a screen printing error mentionned on the strips of the impacted lots. it is written that 5 ul must be pipetted and transferred to the wells "d" and "e". this information is wrong the right volume to transfer is 25 ul as specified in the instruction for use (ref. 20584 version e). this screen printing error could lead to a wrong protocol and pipetting 5 ul instead of 25 ul. when following the wrong protocol there is not issue for the carbapenamase positive strains all correctly identified as positive but there is a potential risk of false positive result for carbapenamase negative strains.