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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There is an issue of false skipped wells and false susceptible misreads with s. agalactiae affecting multiple antimicrobial agents on microscan msp1 msp5 mf5j and mf7j panels processed in a walkaway system. the effect is the potential for false susceptible results for s. agalactiae if the walkaway system reads are not verified. this issue is not panel lot specific nor is it related to a particular model of walkaway instrumentation. no other streptococcal species are affected.