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
An internal inspection indicates that calibrator 2 and conjugate are switched in their positions in the integral. this will result in calibrator 1 rlu's similar to that of background rlu, and calibrator 2 rlu's near expected range. a curve can not be calculated from this data.
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.