Siemens ADVIA Centaur VitD 500 Test Recalled for Fluorescein Interference
Siemens is recalling ADVIA Centaur VitD 500 test kits because fluorescein samples may interfere with assay 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 assay interference rather than direct physical injury or reported illness, fitting the criteria for moderate severity.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 12,787 kits of the ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number 10631021. The product is intended for in vitro diagnostic use in the quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
The recall is due to the potential for samples containing fluorescein to show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D, and the ADVIA Centaur BRAHMS Procalcitonin assays. This interference may affect the accuracy of the test results.
The affected kits were distributed worldwide, including nationwide in the United States and in numerous other countries. Affected lots are identified by kit lots ending in 023, 024, 025, 026, and 027, with expiration dates ranging from July 2014 to April 2015. Users of these kits should stop using the affected products and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 12,787
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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