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 healthcare diagnostics has confirmed that the concentrations for biotin listed in the non- interfering substances section of the current dimension and dimension vista instructions for use for dimension tni dimension vista digxn e2 ferr prl tsh have incorrect units and incorrectly state the level at which biotin does not interfere.
Model Catalog: RF621 (Lot serial: ALL); Model Catalog: K6440 (Lot serial: ALL); Model Catalog: 10464525 (Lot serial: ALL); Model Catalog: K6412 (Lot serial: ALL); Model Catalog: 10489099 (Lot serial: ALL); Model Catalog: K6463 (Lot serial: ALL); Model Catalog: 10488398 (Lot serial: ALL); Model Catalog: K6435 (Lot serial: ALL); Model Catalog: 10488927 (Lot serial: ALL); Model Catalog: K6462 (Lot serial: ALL)
제품 설명
DIMENSION EXL SYSTEM-(TROPONIN) TNI ASSAY;DIMENSION VISTA SYSTEM-FERRITIN (FERR) ASSAY (FLEX);DIMENSION VISTA SYSTEM-THYROID STIMULATING HORMONE (TSH) ASSAY;DIMENSION VISTA SYSTEM LOCI ESTRADIOL (E2) REAGENT;DIMENSION VISTA SYSTEM-LOCI PROLACTIN (PRL) ASS