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
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control - Product Code DHN
원인
The program for a specific immunofluorescent titration system (polymedco polytiter immunofluorescent titration system) was found faulty in that the calibrator 2 value was incorrectly programmed as 1:120 instead of 1:160.
조치
All customers were notified of the problem via phone and letter. Verbal instructions were given of how to change the Calibrator 2 titer to the correct one. A letter instructs customer to return software disc to DiaSorin, remove version 2.8 from the computer and install version 2.8.1.
AL, AZ, CA, CO, FL, KY, MO, NC, NJ, NV, OH, TX, & VA
제품 설명
PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT100 which is programmed for DiaSorin ANAFLUOR Indirect fluroescent Antibody Test For the detection and titration of circulating antinuclear antibodies. REF: 1624, 1662, 1660, 6624, 1604