Home / Recalls / Medical Devices
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol
Recalled May 11, 2022 · FDA recall Z-1022-2022 · Siemens Healthcare Diagnostics
Hazard
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results · FDA Class II
Units
230 units
Sold at
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.
Description
Falsely Elevated Results Observed with Plasma Specimens, could lead a clinician to misinterpret patient results
Product
Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
Manufacturer(s)
Siemens Healthcare Diagnostics, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →