Siemens ADVIA Centaur Calibrator E Recalled for Testosterone Assay Bias
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator E lots 42 and 43 because they show 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, injuries, or illnesses. The hazard is a technical bias in the calibrator affecting assay accuracy, which fits the criteria for a moderate severity recall without reported harm.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling specific lots of the ADVIA Centaur Calibrator E. The recall affects Lot 42 and Lot 43 of the calibrator, which is used for in vitro diagnostic calibration of cortisol, progesterone, and testosterone assays on ADVIA Centaur systems.
The recall is being issued because the affected calibrator lots exhibit bias with the testosterone assay. This issue may impact the accuracy of quantitative testosterone determinations in serum when using the ADVIA Centaur and ADVIA Centaur XP systems.
The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries. Users of the ADVIA Centaur systems should stop using the affected calibrator lots and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN: 10309079 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
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 (9)
- Lot codes/Exp Date: 87226A42 May 9
- 2016
- 55811 A42 May 9
- 53650A42 May 9
- 53624A42 May 9
- 15612A43 November 27
- 17909A43 November 27
- 22868A43 November 27
- 45084A43 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.
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