FDA-Device2022-05-11Class II
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 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
230 units
Manufactured in
333 Coney St, N/A, East Walpole, MA, United States
Products
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1022-2022Don't want to check this manually?
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