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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Customers reported receiving lhb broth tubes which visually appeared to be discolored and/or turbid. some of the tubes visually evaluated were confirmed to have been contaminated. the supplier performed retention samples testing for the two affected lots and found no contamination or turbid broth in any of the tubes however beckman coulter is sending notification letters to customers who received affected lots for their awareness. if a contaminated tube were inadvertently used it could result in mis-interpretation of susceptibility.