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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 374
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Siemens Healthcare Diagnostics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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