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 recovery of the mcv parameter for the abnormal ii level of coulter 5c cell control may recover values above the upper expected range limit.
Model Catalog: ABNORMAL I (Lot serial: 100348H-100351K); Model Catalog: NORMAL (Lot serial: 112198K-11210K); Model Catalog: ABNORMAL II (Lot serial: 112198K-11210K); Model Catalog: ABNORMAL I (Lot serial: 112198K-11210K); Model Catalog: NORMAL (Lot serial: 100128K-100152K); Model Catalog: ABNORMAL II (Lot serial: 100128K-100152K); Model Catalog: ABNORMAL I (Lot serial: 100128K-100152K); Model Catalog: NORMAL (Lot serial: 869400F-869900F); Model Catalog: ABNORMAL II (Lot serial: 869400F-869900F); Model Catalog: ABNORMAL I (Lot serial: 869400F-869900F); Model Catalog: NORMAL (Lot serial: 102785K-102794K); Model Catalog: ABNORMAL II (Lot serial: 102785K-102794K); Model Catalog: ABNORMAL I (Lot serial: 102785K-102794K); Model Catalog: NORMAL (Lot serial: 102866K-102880K); Model Catalog: ABNORMAL II (Lot serial: 102866K-102880K); Model Catalog: ABNORMAL I (Lot serial: 102866K-102880K); Model Catalog: NORMAL (Lot serial: 111220K-111224K); Model Catalog: ABNORMAL II (Lot serial: 111220K-111224K); Model Catalog: ABN