Siemens ADVIA Centaur Vitamin D Test Recalled for Fluorescein Interference
Siemens Healthcare Diagnostics is recalling 40,266 ADVIA Centaur Systems VitD Total 100 test kits because samples containing fluorescein may interfere with the 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential diagnostic interference that could lead to incorrect medical decisions, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 40,266 units of the ADVIA Centaur Systems VitD Total 100 test, Ready Pack (SMN 10699201). The product is intended for in vitro diagnostic use in the quantitative determination of Vitamin D on the ADVIA Centaur and ADVIA Centaur XP analyzers. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recall is due to the potential for interference in test results. Samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D, and the ADVIA Centaur BRAHMS Procalcitonin assays. This interference could lead to inaccurate quantitative determinations of Vitamin D.
The affected lots are identified by kit lots ending in 050, 051, 052, 053, and 054, with expiration dates ranging from August 2014 to March 2015. The products were distributed worldwide, including nationwide in the United States and in numerous other countries. Users of these kits should stop using the affected lots and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. 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
- 40,266
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.
See all 7 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · diagnostic interference
See all →- ModerateOrtho-Clinical VITROS Chemistry BuBc Slides Recalled for Etrombopag Interference
FDA (Devices) · 2020-09-02
- HighBeckman Coulter Enzymatic Creatinine Reagent Recalled for Potential Diagnostic Interference
FDA (Devices) · 2020-03-11
- HighBeckman Coulter Uric Acid Reagent Recalled for Acetaminophen Interference
FDA (Devices) · 2020-03-11
- ModerateAbbott Recalls Architect Lactic Acid Assay Due to Drug Interference
FDA (Devices) · 2016-11-16
- ModerateSiemens ADVIA Chemistry Triglycerides Reagent Recalled for Interference
FDA (Devices) · 2016-05-18
Similar recalls
- ModerateSiemens ADVIA Centaur Vitamin D Assay Recalled for Negative Bias
FDA (Devices) · 2013-04-24
- ModerateSiemens Vitamin D Total Assay Recalled for Specimen Correlation Issues
FDA (Devices) · 2016-11-23
- HighSiemens Vitamin D Total Assay Recalled for Plasma Sample Bias
FDA (Devices) · 2016-11-23
- ModerateSiemens ADVIA Centaur Vitamin D Calibrator Recalled for Negative Bias
FDA (Devices) · 2013-04-24
- HighADVIA Centaur SARS-CoV-2 Antigen Assay Recalled for Insufficient Validation Data
FDA (Devices) · 2021-11-10
- SevereSiemens Recalls ADVIA Centaur TnI-Ultra Assay Kits Due to Reagent Appearance
FDA (Devices) · 2014-07-09