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.
데이터 추가 비고
원인
The hemoglobin (hgb) values for the following s-cal kits were incorrectly assigned 0.3 g/dl (3g/l) lower than the actual value: s-cal calibrator kit (1 x 4.2 ml) part # 179310 kit # 1169206f & 1169207f vial lot # 4705. s-cal calibrator kit (2 x 4.2 ml) part # 624519 kit # 1158251f vial lot # 4705. s-cal calibrator kit (1 x 3.3 ml) part # 628026 kit # 2983070f vial lot # 112972830.
Model Catalog: 628026 (Lot serial: VIAL LOT 112972830); Model Catalog: 179310 (Lot serial: KIT LOT 1169206F & 1169207F); Model Catalog: 179310 (Lot serial: VIAL LOT 112972830); Model Catalog: 628026 (Lot serial: KIT LOT 2983070F); Model Catalog: 624519 (Lot serial: KIT LOT 2983070F); Model Catalog: 179310 (Lot serial: KIT LOT 2983070F); Model Catalog: 628026 (Lot serial: KIT LOT 1158251F VIAL LOT 4705); Model Catalog: 624519 (Lot serial: KIT LOT 1158251F VIAL LOT 4705); Model Catalog: 179310 (Lot serial: KIT LOT 1158251F VIAL LOT 4705); Model Catalog: 628026 (Lot serial: VIAL LOT 4705); Model Catalog: 624519 (Lot serial: VIAL LOT 4705); Model Catalog: 179310 (Lot serial: VIAL LOT 4705); Model Catalog: 628026 (Lot serial: KIT LOT 1169206F & 1169207F); Model Catalog: 624519 (Lot serial: KIT LOT 1169206F & 1169207F); Model Catalog: 624519 (Lot serial: VIAL LOT 112972830)