In Vitro Diagnostic Estradiol Test Recalled for Falsely Elevated Results
Siemens Healthcare Diagnostics is recalling Atellica IM Enhanced Estradiol (eE2) 500T diagnostic kits that produce falsely elevated test results in plasma specimens, which could lead clinicians to misinterpret patient 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 a Class II medical device recall involving a risk-of-harm product (diagnostic test producing incorrect results that could lead to clinical misinterpretation and potential harm) with no reported injuries. Per the severity rubric, risk-of-harm products where injury has not yet been reported qualify as High (3).
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling all lots of Atellica IM Enhanced Estradiol (eE2) 500T, an in vitro diagnostic test kit used to measure estradiol levels in blood plasma. The recall is due to falsely elevated test results observed in plasma specimens, which could lead clinicians to misinterpret patient results.
The affected product has been distributed worldwide, including throughout the United States and to countries including Austria, Belgium, Brazil, France, India, Italy, Netherlands, Spain, Sweden, Switzerland, Turkey, and the United Kingdom, among others. A total of 374 units are affected.
Healthcare providers and facilities using the Atellica IM Enhanced Estradiol (eE2) 500T should verify that they have affected units by checking their lot numbers against the UDI codes listed in the FDA recall notice. Affected lots should be removed from service. Facilities should contact Siemens Healthcare Diagnostics for instructions regarding device returns and replacement options.
The recalled product
- Product
- Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10995562 All lots
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
- inaccurate-results
Distribution
Distributed nationwide across the United States.
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