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
Siemens confirmed a negative bias in patient medians of approximately 5 to 20% using the igf-i assay as compared to the reference range medians provided in the igf-i instructions for use (ifu) with kit lots released august 2008 through july 2011.
Model Catalog: L5KGF2 (Lot serial: LOTS 189-227); Model Catalog: L2KGF2 (Lot serial: LOT 441 TO 492); Model Catalog: LKGF1 (Lot serial: LOT 315 TO 335); Model Catalog: LKGF1 (Lot serial: LOT 315-335)
제품 설명
IMMULITE 2500 SYSTEM-IGF-1 (INSULIN LIKE GROWTH HORMONE ASSAY)