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 a reduced onboard stability for the 100 tests kit size with the afp application file version 104 and tpsa application file version 103. the onboard stability of the 100 tests kit was harmonized with the 200 tests kit to the stability claim of (28 days) to allow the use of both reagent kit sizes in parallel on the cobas e 602 with the new software version 04-01. ^.
Model Catalog: 04641655190 (Lot serial: All lots); Model Catalog: 04491742190 (Lot serial: All lots); Model Catalog: 04481798190 (Lot serial: All lots)