Siemens ADVIA Centaur Calibrator E Recalled for Testosterone Assay Bias
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator E lots 42 and 43 due to bias in the testosterone assay.
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 or injuries, fitting the criteria for a moderate severity recall involving a diagnostic device defect.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling specific lots of the ADVIA Centaur Calibrator E. The affected product is used for in vitro diagnostic calibration of cortisol, progesterone, and testosterone assays on ADVIA Centaur systems.
The recall is being conducted because the calibrator exhibits bias with the testosterone assay. The affected lots are identified by codes ending in 42 and 43, with expiration dates ranging from May 9, 2016, to November 27, 2016.
The product was distributed worldwide, including nationwide in the United States and to various international locations. Users of the affected calibrator lots should stop using the product and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10321075 ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone. ADVIA…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
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 (10)
- Lot code/ Exp.Date: 86344A42 May 9
- 2016
- 55437A42 May 9
- 54801A42 May 9
- 53651A42 May 9
- 53625A42 May 9
- 15610A43 November 27
- 18375A43 November 27
- 24990A43 November 27
- 38988A43 November 27
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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 3 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 · assay bias
See all →- HighSiemens Dimension tacrolimus reagent cartridges may bias results positively
FDA (Devices) · 2026-06-17
- HighParathyroid hormone assay recalled over falsely depressed results at low range
FDA (Devices) · 2025-11-05
- ModerateSiemens ADVIA Centaur Calibrator E Recalled for Testosterone Assay Bias
FDA (Devices) · 2016-03-16
- ModerateSiemens ADVIA Centaur Calibrator E Recalled for Testosterone Assay Bias
FDA (Devices) · 2016-03-16
Similar recalls
- ModerateSiemens Calibrator E Recalled for Positive Bias in Cortisol and Progesterone Assays
FDA (Devices) · 2014-11-12
- ModerateSiemens ADVIA Centaur Calibrator 30 Recalled for Negative Bias
FDA (Devices) · 2018-02-14
- ModerateSiemens ADVIA Centaur Calibrator A Kits Recalled for FT4 Bias
FDA (Devices) · 2017-03-08
- ModerateSiemens ADVIA Centaur Vitamin D Calibrator Recalled for Negative Bias
FDA (Devices) · 2013-04-24
- LowSiemens ADVIA Centaur FSH Calibrator B Recalled for Analytical Sensitivity Failure
FDA (Devices) · 2012-09-26
- LowSiemens ADVIA Centaur Calibrator A Recalled for T4 Assay Inaccuracy
FDA (Devices) · 2013-08-21