Siemens ADVIA Centaur Folate 100 Test Kits Recalled for Elevated Results
Siemens is recalling 12,796 ADVIA Centaur Folate 100 test kits because homocysteine assays may cause elevated folate 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, and the hazard involves inaccurate test results rather than direct physical injury or a high-risk pathogen, fitting the criteria for a moderate severity recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 12,796 units of the ADVIA Centaur Folate 100 test kit, intended for in vitro diagnostic (IVD) use in measuring folate in serum or red blood cells. The recall covers all lots of the product, identified by SMN:10310308.
The recall was initiated because the homocysteine assay may cause elevated results in the folate assay. This issue could lead to inaccurate diagnostic readings for patients.
The affected products were distributed nationwide and in numerous foreign countries, including Armenia, Austria, Bahrain, Belgium, and others. Healthcare facilities and laboratories that possess these test kits should stop using them and contact Siemens Healthcare Diagnostics for further instructions on returns or replacements.
The recalled product
- Product
- Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 12,796
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 3 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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