Device Recall DiaSorin LIAISON Estradiol II Gen assay

  • Model / Serial
    Catalog Number 31 0680, 31 0680-CN
  • Product Classification
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    USA (nationwide) Distribution and Worldwide Distribution including the states of : AR, AZ, CA, FL, ID, NJ, NV, NY and PA.., and to the countries of : Saudi Arabia, Colombia, Mauritius, Iraq, Mongolia, Greece, Albania, Austria, Bosnia, Bosnia Herzegovina, Belarus, Bulgaria, Macedonia, Poland, Serbia, Dominican Rep., Tunisia, Paraguay, Hungary, Jordan, Egypt, Belgium, Caribbean, Germany, Brazil, Mexico, Italy, India, South Korea, Cyprus, Bangladesh, Morocco, Chile, Bahrain, Palestine, Utd.Arab.Emir., Kosovo, Uruguay, Venezuela, Hungary, Australia, Vietnam, Sri Lanka, Turkey, Vietnam, Romania, Mauritius, Ecuador, Lebanon, Nepal, Argentina, Hong Kong, China and Canada.
  • Product Description
    LIAISON Estradiol II Gen, 310680, 310680-CN || The DiaSorin LIAISON Estradiol II Gen assay is a chemiluminescent immunoassay (CLIA) intended for the quantitative determination of estradiol in human serum. Assay results should be used in conjunction with other clinical and laboratory data to assist in the diagnosis and management of conditions involving an excess or deficiency of estradiol. The test has to be performed on the LIAISON Analyzer Family.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Diasorin Inc., 1951 Northwestern Ave S, Stillwater MN 55082-7536
  • Manufacturer Parent Company (2017)
  • Source
    USFDA