Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1689-2018·Announced 2018-05-16

Siemens ADVIA Centaur Folate Recalled for Biotin Interference Risk

Siemens Healthcare Diagnostics is recalling ADVIA Centaur Folate assays because biotin interference levels are not listed in the instructions, potentially affecting test accuracy.

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. The hazard is a potential for inaccurate test results due to biotin interference, which fits the criteria for a moderate severity recall involving labeling/instruction issues without reported harm.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Centaur Folate (FOL) assay. The recall is due to the fact that the concentrations of biotin that do not interfere with the test are not currently listed in the instruction for use. This omission means the assay is susceptible to interference from biotin, which could impact the accuracy of the test results.

The affected products were distributed nationwide in the United States, as well as in Canada, Mexico, and Thailand. The recall includes specific lot numbers for the ADVIA Centaur Folate (REF), (100 Test), and (500 Test) versions, as detailed in the agency's structured product information.

Healthcare providers and laboratories using these assays should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions or replacements. Patients who have had tests performed using these specific lots may want to consult their healthcare provider regarding the potential impact of biotin interference on their results.

The recalled product

Product: ADVIA Centaur¿ Folate (FOL)
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: biotin-interference
inaccurate-results

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 (6)

ADVIA Centaur¿ Folate
acid
folic
radioimmunoassay
SMN 10310308
10325366

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 24 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.

See all 24 products in this recall →

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Same hazard · biotin interference