Siemens Vitamin D Total Assay Recalled for Specimen Correlation Issues
Siemens Healthcare Diagnostics is recalling Vitamin D Total Assay kits due to a negative bias in plasma samples compared to serum samples.
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 a potential for inaccurate test results (negative bias) rather than a direct physical injury or high-risk pathogen, fitting the criteria for moderate severity.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the Siemens ADVIA Centaur Vitamin D Total Assay (SMN 10699201, 100 test). The recall involves 69,781 kits distributed nationwide and to numerous foreign countries.
The recall was initiated because of a change in the correlation between serum and plasma specimen tubes. Specifically, the assay exhibits a negative bias when using plasma samples compared to serum samples. This discrepancy may affect the accuracy of test results depending on the specimen type used.
Healthcare facilities and laboratories that have received these kits should stop using them and contact Siemens Healthcare Diagnostics for further instructions. Consumers are not directly affected as this is a professional in-vitro diagnostic product.
The recalled product
- Product
- Siemens ADVIA Centaur¿ Vitamin D Total Assay SMN 10699201 (100 test)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 69,781
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 lot codes
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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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