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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The affected lot numbers of the reagent may display graininess that could be mis-interpreted as a false positive result.
Model Catalog: PL.1080 (Lot serial: PL1080 LOT 6087); Model Catalog: PL.1080 (Lot serial: PL1081 LOT 5927); Model Catalog: PL.1080 (Lot serial: PL1080 Lot 6066); Model Catalog: PL.1081 (Lot serial: PL1081 LOT 5927); Model Catalog: PL.1080 (Lot serial: PL1081 LOT 6067); Model Catalog: PL.1081 (Lot serial: PL1081 LOT 6067); Model Catalog: PL.1080 (Lot serial: PL1081 LOT 6088); Model Catalog: PL.1081 (Lot serial: PL1081 LOT 6088); Model Catalog: PL.1081 (Lot serial: PL1080 Lot 6066); Model Catalog: PL.1081 (Lot serial: PL1080 LOT 6240); Model Catalog: PL.1080 (Lot serial: PL1080 LOT 6240); Model Catalog: PL.1081 (Lot serial: PL1080 LOT 6087); Model Catalog: PL.1081 (Lot serial: PL1081 LOT C6375); Model Catalog: PL.1080 (Lot serial: PL1081 LOT 6127); Model Catalog: PL.1081 (Lot serial: PL1081 LOT 6127); Model Catalog: PL.1080 (Lot serial: PL1081 LOT 6237); Model Catalog: PL.1081 (Lot serial: PL1081 LOT 6237); Model Catalog: PL.1080 (Lot serial: PL1081 LOT C6340); Model Catalog: PL.1081 (Lot serial: PL1081 LOT C6