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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A portion of gamma-glutamyl transferase reagent kit lot number 360646 for use on the advia? 1200 1800 2400 and xpt chemistry systems may contain (r1) reagent wedges that have incorrectly printed and encoded barcode information. when placed on board the system the affected r1 reagent wedge is not readable and is not recognized by the system. note: reagent containers that have the correct barcode can be used as is on the system. (r2 reagent has the correct barcode) correct r1 barcode: 740442164612736439 incorrect r1 barcode: 747442164612736439.