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
Beckman coulter has determined through internal investigation and customer feedback that the affected assays are susceptible to biotin interference with patient samples containing 100 ng/ml of biotin. specimens that contain high levels of biotin may cause: false low results for the access gi monitor and thyroglobulin assays and may cause false high results for the access free t4 and total t3 assays.
Model Catalog: 387687 (Lot serial: ALL LOTS); Model Catalog: 33830 (Lot serial: ALL LOTS); Model Catalog: 33860 (Lot serial: ALL LOTS); Model Catalog: 33880 (Lot serial: ALL LOTS)
제품 설명
387687 GI MONITOR (UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM);33830 TOTAL T3 (UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM);33860 THYROGLOBULIN (UNICEL DXI 600 ACCESS IMMUNOASSAY SYSTEM);33880 FREE T4 (UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM);33880 FREE T4 (A