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
Software revision 1.7 contains an error in the bioassay module if used in bq units of measure. this will result in a calculated net bioassay value which is higher than the true bioassay value.
Model Catalog: 5430-0106 (Lot serial: Upgrade S/N CNV-366 to CNV-374); Model Catalog: 5430-0118 (Lot serial: Upgrade S/N CNV-366 to CNV-374); Model Catalog: 5430-0087 (Lot serial: Upgrade S/N CNV-366 to CNV-374); Model Catalog: 5430-0077 (Lot serial: Upgrade S/N CNV-366 to CNV-374); Model Catalog: 5430-0076 (Lot serial: Upgrade S/N CNV-366 to CNV-374); Model Catalog: 5430-0119 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0118 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0107 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0106 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0103 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0087 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0077 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0076 (Lot serial: S/N 900287 through 900306); Model Catalog: 5430-0103 (Lot serial: Upgrade S/N CNV-366 to CNV-374); Model Catalog: 5430-0119 (Lot serial: Upgrade S/N CNV-366 to CNV-374)