Estradiol Diagnostic Device Recalled for Falsely Elevated Test Results
An estradiol diagnostic device has been recalled because it produces falsely elevated test results in plasma specimens. These inaccurate results could cause clinicians to misinterpret patient test results.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device recall without reported hospitalizations or adverse events. The device produces falsely elevated test results, posing a risk of harm through potential misdiagnosis. Since no reported injuries or illnesses are documented, this meets the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T, an in vitro diagnostic device used to measure estradiol levels in patient blood samples. This recall affects all lot numbers of the device, with 88 units distributed.
The device has been found to produce falsely elevated test results when analyzing plasma specimens. These inaccurate results could lead clinicians to misinterpret patient test results and make inappropriate clinical decisions based on incorrect information.
The affected device was distributed worldwide, including throughout the United States and to numerous countries including Austria, Belgium, Brazil, Bulgaria, Cyprus, Denmark, Egypt, Estonia, Finland, France, Greece, India, Ireland, Israel, Italy, Kazakhstan, Latvia, Lithuania, Malta, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden, Switzerland, Turkey, Ukraine, and the United Kingdom.
Healthcare facilities that have received this device should contact Siemens Healthcare Diagnostics, Inc. for instructions on how to handle affected inventory and for guidance on reviewing patient results obtained using the device.
The recalled product
- Product
- ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative detection of estradiol SMN: 10697757 All lots
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- inaccurate-results
Distribution
Distributed nationwide across the United States.
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