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.
Varicella zoster elisa kit assay was producing invalid runs on the eti-max 3000 automated microtiter plate instrument and/or false negative results.
조치
Kit was initially placed on hold. Later Kit was discontinued and an alternate which would run correctly on the ETI-Max 3000 automated platform was found and offered to customers.
Varcella Zoster ELISA Kit for the detection of IgG antibodies to varicella zoster virus in human serum, Catalog No.: 4620. DiaSorin Stillwater, Minnesota 55082-0285