Estradiol Diagnostic Test Recall: Risk of Falsely Elevated Results
Siemens Healthcare Diagnostics is recalling Atellica IM Enhanced Estradiol diagnostic test kits (all lots) due to falsely elevated results in plasma specimens. These inaccurate results could lead clinicians to misinterpret patient data.
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 an FDA Class II recall with no reported illnesses or injuries. The hazard—falsely elevated diagnostic results—constitutes a risk-of-harm product where patient injury has not yet been reported, warranting a High severity rating.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling Atellica IM Enhanced Estradiol (eE2) (REF) 500T in vitro diagnostic test kits (all lot numbers) used to measure estradiol levels in laboratory specimens.
The product has been found to produce falsely elevated results when testing plasma specimens. These inaccurate readings could lead clinicians to misinterpret patient test results and potentially affect clinical decision-making.
This recall affects 230 units distributed worldwide, including the United States and numerous international locations.
Healthcare facilities and laboratories using this product should discontinue use immediately and contact Siemens Healthcare Diagnostics for replacement or further guidance.
The recalled product
- Product
- Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 11206250 All lots
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 230
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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