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
Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control - Product Code DBM
원인
The data reduction program written for a specific automated microtiter plate instrument (bio-tek elx800 reader) was found to be faulty. this program is used to calculate the cut off values for diastat anti-mitochondrial antibody kit. program should include a borderline specification to indicate repeat testing is needed.
조치
A notification letter and effectiveness check form was sent to consignees. This letter recommended that users manually verify results using the specifications outlined in the package insert until a new software version is installed.