Siemens ADVIA Centaur Estradiol Test Recalled for Falsely Elevated Results
Siemens Healthcare is recalling all lots of the ADVIA Centaur Enhanced Estradiol diagnostic test because plasma specimens can produce falsely elevated results, potentially leading 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 an FDA Class II medical device recall involving a diagnostic test that can produce falsely elevated results. While the hazard poses a risk of clinical misinterpretation and potential patient harm, no illnesses or injuries have been reported. Per the rubric, recalls with theoretical risk of harm and no reported injuries score as High (3).
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Centaur Enhanced Estradiol (eE2) 500T diagnostic test. This in vitro diagnostic device is used for quantitative determination of estradiol levels in patient samples.
The recall was initiated because the device can produce falsely elevated results when analyzing plasma specimens. These inaccurate results could lead clinicians to misinterpret patient estradiol levels.
The affected device is identified by SMN 10491445, and all lot numbers are included in this recall. Approximately 952 units have been distributed worldwide, including throughout the United States and internationally to countries including Austria, Belgium, Brazil, Bulgaria, Cyprus, Denmark, Egypt, Finland, France, Greece, India, Ireland, Israel, Italy, Latvia, Lithuania, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden, Switzerland, Turkey, United Kingdom, and others.
The recalled product
- Product
- ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determination of estradiol SMN: 10491445 All lots
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 952
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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