Siemens ADVIA Centaur DHEAS Assay Recalled for Temperature Sensitivity
Siemens Healthcare is recalling ADVIA Centaur DHEAS assays because room temperature changes can alter test 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 potential inaccuracies in test results due to environmental factors rather than direct physical injury or contamination.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Centaur DHEA-504 (DHEAS) 50 Test assay, catalog number 06489701. This in vitro diagnostic immunoassay is used to measure dehydroepiandrosterone sulfate (DHEAS) levels in human serum and plasma on ADVIA Centaur and ADVIA Centaur XP systems.
The recall is due to the assay's sensitivity to room temperature. The operating range for the ADVIA Centaur systems is 18°C to 30°C (64.4°F to 86.0°F). Changes in room temperature may increase or decrease assay results, depending on the specific assay and system used.
The recall involves 12,976 units distributed worldwide, including the United States and numerous international locations. All lot codes are affected. Users should contact Siemens Healthcare Diagnostics, Inc. for further instructions regarding the recall.
The recalled product
- Product
- Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The ADVIA Centaur DHEAS assay is an in vitro diagnostic immunoassay for the quantitative determination of dehydroepiandrosterone sulfate (DHEAS) in human serum and plasma using the ADVIA Centaur and ADVIA…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 12,976
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 7 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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