Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1688-2018·Announced 2018-05-16

Siemens ADVIA Centaur DHEA-SO4 Recalled for Incorrect Biotin Interference Data

Siemens Healthcare Diagnostics is recalling ADVIA Centaur DHEA-SO4 kits because the instructions for use incorrectly state the level at which biotin does not interfere.

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 hazard is a labeling error regarding interference levels rather than a direct contamination or structural defect, fitting the criteria for moderate severity involving minor labeling errors or low-risk issues.

Plain-English summary

Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur DHEA-SO4 kits. The recall is due to an error in the instructions for use, which incorrectly state the level at which biotin does not interfere with the test results.

The affected product is the ADVIA Centaur DHEA-SO4 radioimmunoassay kit. The recall covers specific lots distributed nationwide in the United States, as well as in Canada, Mexico, and Thailand. The source text notes that similar labeling errors regarding biotin interference levels were also identified in other Siemens products, including Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, and ADVIA Centaur Cyclosporine.

Consumers and healthcare facilities should stop using the affected kits and contact Siemens Healthcare Diagnostics for further instructions or a replacement. This recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product: ADVIA Centaur¿ DHEA-SO4
Manufacturer: Siemens Healthcare Diagnostics, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: mis-labeling
interference

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 (3)

ADVIA Centaur¿ DHEA-SO4
radioimmunoassay
dehydroepiandrosterone (free and sulfate)

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 →

Same manufacturer · Siemens Healthcare Diagnostics, Inc.

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