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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An internal complaint identified a barcode conflict between immulite/immulite 1000 follicle- stimulating hormone (fsh) lkfs reagent wedge lots 351 and 352 where both reagent wedge lots were displayed by the software as lot '01'. this could result in the incorrect reagent wedge lot being used for a kit lot if both reagent wedges were on the instrument at the same time. an internal investigation concluded that there would be no impact to patient or quality control results if reagent wedges were mis-matched. customer complaint escalations identified "adjustment overdue" or "expired" flags when immulite /immulite 1000 fsh reagent lot 351 was stored in system history and reagent lot 352 was introduced to the system. the customer (field) confirmed "adjustment overdue" or "expired" flags could not be replicated internally. note: kit lot 351 expired august 31 2014 kit lot 352 expires october 31 2014.