FDA-Device2022-05-11Class II
ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots
Siemens Healthcare Diagnostics, Inc.
Hazard
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Sold states
Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Brazil, Bulgaria, Burkina, Faso Country AG, Cyprus, Denmark, Egypt, Estonia, Finland, France, French Polynesia, Georgia, Greece, Guadeloupe, India, Ireland, Israel, Italy, Kazakhstan, Latvia, Lithuania, Macedonia, Malta, Morocco, Nepal, Netherlands, Norway, Palestinian Ter, Paraguay, Poland, Portugal, Qatar, Romania, Russian Fed., Slovakia, Spain, Sweden, Switzerland, Turkey, Turkmenistan, U.A.E., Ukraine, United Kingdom, Vatican city.
Affected count
88 units
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1025-2022Don't want to check this manually?
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