U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
데이터 추가 비고
Extractable Antinuclear Antibody, Antigen And Control - Product Code LLL
원인
An error in the bio-tek elx800 microplate reader programming specifications for the ena screen assay exists in that an equivocal (borderline) zone is missing.
조치
Customers were sent a notification letter informing customers of an error in the Bio-Tek ELx800 programming specifications. Customers were asked to repeat testing for historical runs for RSLT (S/CO) that read from 0.95 to 1.0. A response form is asked to be faxed back to DiaSorin.