Siemens Progesterone Test Recalled Due to DHEA-S Interference
Siemens Healthcare Diagnostics is recalling Dimension Vista LOCI 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 due to chemical interference rather than a direct physical injury or high-risk pathogen, fitting the criteria for moderate severity.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 1,148 units of the Dimension Vista LOCI Progesterone test (Catalog Number: K6464; Siemens Material Number: 10461743). The product is used for in vitro diagnostic purposes to quantitatively determine progesterone levels in serum on specific ADVIA Centaur systems.
The recall was initiated because the presence of DHEA-S (dehydroepiandrosterone sulfate) in patient samples causes falsely elevated progesterone results. This interference can lead to inaccurate diagnostic readings.
The affected units were distributed nationwide in the United States, including Puerto Rico. Specific lot codes involved in the recall include 16193BB, 16200BA, 16214BA, 16235BB, 16250BA, 16270BA, 16291BA, and 16319AA. Healthcare facilities and laboratories should stop using the affected lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product Usage: For in vitro diagnostic use in the quantitative determination of progesterone in serum and using the ADVIA Centaur¿, ADVIA Centaur XP, ADVIA Centaur XPT and ADVIA…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 1,148
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)
- 16193BB 16200BA 16214BA 16235BB 16250BA 16270BA 16291BA 16319AA
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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