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.
Standards used in the gammacoat androstenedione radioimmunoassay kit appeared yellowish in color and were gelatinous upon reconstitution.
조치
Customers were sent a customer notification letter identifying the product and the problem and requesting a response identifying the number of replacement kits needed.