Siemens Estradiol Test Recalled Due to Potential False Results
Siemens is recalling ADVIA Centaur Enhance Estradiol tests because the drug fulvestrant may cause falsely elevated 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential diagnostic errors (falsely elevated results) due to drug interference, which fits the criteria for moderate severity involving low-risk contamination or precautionary measures without reported injuries.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Centaur Enhance Estradiol Test (Test Code eE2). The affected catalog numbers are 10490889, 10491445, and 10697757. The recall covers 33,604 units distributed worldwide, including the United States and numerous other countries.
The recall is being conducted because the drug fulvestrant (Faslodex) may cause falsely elevated estradiol results when using this test. This is an in vitro diagnostic test used for the quantitative determination of estradiol in human serum and plasma.
Healthcare facilities and laboratories should stop using the affected test kits and contact Siemens Healthcare Diagnostics for further instructions on the recall.
The recalled product
- Product
- Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757 Product Usage: For in vitro diagnostic use in the quantitative determination of estradiol in human serum and plasma (heparinized and EDTA) using the ADVIA Centaur¿, ADVIA…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 33,604
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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