Siemens ADVIA Centaur Vitamin D Calibrator Recalled for Negative Bias
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Vitamin D Calibrators due to negative bias in patient samples.
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, but the source text does not report any hospitalizations, injuries, or illnesses, fitting the criteria for a moderate severity recall involving potential diagnostic inaccuracy.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Centaur Vitamin D Calibrator 2-pack (Reference Number 10493589). The recall involves 372 packs of calibrators distributed nationwide. The affected lot numbers are C3410, 95197A10, 95031A10, 94607A10, and 94155A10, all with an expiration date of August 16, 2013.
The recall was initiated because the calibrators may cause negative bias in patient samples used for the quantitative determination of Vitamin D. This issue could lead to inaccurate test results for patients.
Healthcare facilities and laboratories that have received these calibrators should stop using them and contact Siemens Healthcare Diagnostics for instructions on return or replacement.
The recalled product
- Product
- ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the quantitative determination of Vit D.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 372
Distribution
Distributed nationwide across the United States.
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.
See all 4 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 · inaccurate diagnosis
See all →- HighBiomerieux VITEK 2 AST-N461 Test Kit Recalled for Card Pouch Damage
FDA (Devices) · 2026-09-30
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- HighBioFire Spotfire Respiratory/Sore Throat Panel Recall for False Negatives
FDA (Devices) · 2026-05-13
- HighDiagnostic Kit Recall: Falsely Elevated Mold Allergen Test Results
FDA (Devices) · 2022-12-21
- HighConfirm Biosciences Recalls Healgen COVID-19 Rapid Test Cassettes
FDA (Devices) · 2021-02-24
Similar recalls
- 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 Recalls ADVIA Centaur CKMB Calibrator Kits Due to Potential Bias
FDA (Devices) · 2018-10-24
- ModerateSiemens ADVIA Centaur Calibrator E Recalled for Testosterone Assay Bias
FDA (Devices) · 2016-03-16
- ModerateSiemens ADVIA Centaur Calibrator A Kits Recalled for FT4 Bias
FDA (Devices) · 2017-03-08
- ModerateSiemens ADVIA Centaur iPTH Calibrator Recalled for Variability
FDA (Devices) · 2013-06-12