Medical Diagnostic Test Kit Issues Falsely Elevated Estradiol Results
Siemens Healthcare is recalling ADVIA Centaur Enhanced Estradiol diagnostic kits because plasma specimens may show falsely elevated results, potentially leading clinicians to misinterpret patient test 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 an FDA Class II recall of a diagnostic device. The source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential for clinical misinterpretation through false diagnostic results, which constitutes a risk-of-harm scenario without reported actual injury.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Centaur Enhanced Estradiol (eE2) 100T, an in vitro diagnostic test used to measure estradiol levels in patient samples. The product has been distributed worldwide, with 2,315 units affected.
The test can produce falsely elevated results when analyzing plasma specimens. These incorrect results could lead clinicians to misinterpret patient test outcomes and make inappropriate clinical decisions based on inaccurate diagnostic data.
The recall affects all lot numbers of the product. Affected lots are identified by the UDI codes provided by the manufacturer.
Healthcare providers using this test should contact Siemens Healthcare Diagnostics for instructions on how to proceed. Patients who may have been tested with affected kits should consult with their healthcare provider about the potential impact on their test results.
The recalled product
- Product
- ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10490889 All lots
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 2,315
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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