Siemens ADVIA Centaur Vitamin D Assay Recalled for Negative Bias
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Assay kits due to negative bias in patient 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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity recall involving potential diagnostic inaccuracy.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Centaur Vitamin D Assay (500 tests), Reference Number 10631021. The recall involves 4,133 units distributed nationwide. The affected lots include Ready Pack Lot Numbers 134009, 134010, and 134011, with specific kit lot numbers and expiration dates ranging from April 28, 2013, to August 12, 2013.
The recall is being conducted because of negative bias in patient samples for Vitamin D. This issue may affect the accuracy of quantitative Vitamin D determinations. The product is intended for use in clinical laboratories.
Healthcare facilities and laboratories that have received these specific lots should stop using the affected kits and contact Siemens Healthcare Diagnostics for further instructions or a replacement.
The recalled product
- Product
- ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative determination of Vit D.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 4,133
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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