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
System, Test, Vitamin D - Product Code MRG
원인
Results of an internal inspection show lot 114439e to have calibrator 1 and calibrator 2 switched in their position in the integral. this results in an inability to calculate a curve, due to the reversal of calibrator values.
조치
DiaSorin Customer Notification dated 02/14/05 was sent to customers instructing them to destroy all kits from the affected lot number. Customers were also asked to complete and return a form indicating how many kits were destroyed.