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.
What this means for you
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 →- 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
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
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 →- 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
- HighAmeditech Recalls First Check 4 Panel Drug Cups Due to Performance Failures
FDA (Devices) · 2020-10-07