Siemens ADVIA Centaur Progesterone Test Recalled for DHEA-S Interference
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Progesterone tests because DHEA-S causes falsely elevated 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 inaccurate diagnostic results (falsely elevated) rather than direct physical injury or a high-risk pathogen, fitting the Moderate criteria for low-risk contamination or labeling/accuracy errors.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur Progesterone tests (Catalog Numbers 10310305, 10315522, and 10333111). The recall involves 76,107 units distributed nationwide in the United States, including Puerto Rico.
The recall was initiated because the presence of DHEA-S (dehydroepiandrosterone sulfate) in patient samples causes falsely elevated progesterone results. This in vitro diagnostic test is used for the quantitative measurement of progesterone in human serum and plasma on the Dimension Vista System.
Healthcare facilities and laboratories that have received these specific catalog numbers should stop using the affected products and contact Siemens Healthcare Diagnostics for instructions on return or replacement.
The recalled product
- Product
- ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG method is an in vitro diagnostic test for the quantitative measurement of progesterone in human serum and plasma on the Dimension Vista¿System. Progesterone measurements are used…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 76,107
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)
- SMN: 10333111: 84848274 89946274 14006275 33598275 49907276 66978276
Distribution
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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