Siemens ADVIA Centaur Calibrator E Recalled for Testosterone Assay Bias
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Calibrator E packs due to bias in the testosterone assay. The recall covers 519 packs distributed worldwide.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The specific hazard is assay bias, which is a functional defect rather than a direct physical injury risk.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 519 packs of ADVIA Centaur Calibrator E (Catalog Number 04636889, SMN 10335532). The recall is due to bias with the testosterone assay in the affected lots.
The affected lots are 91005A42 and 53698A42, both with an expiration date of May 9, 2016. These products were distributed nationwide in the United States and internationally to numerous countries including Canada, Australia, and Brazil.
The product is intended for in vitro diagnostic use in calibration for cortisol, progesterone, and testosterone assays on ADVIA Centaur systems. Users should stop using the affected calibrators and contact Siemens Healthcare Diagnostics for instructions on return or replacement.
The recalled product
- Product
- Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Number: 04636889 SMN: 10335532 ADVIA Centaur¿ Calibrator E For in vitro diagnostic use in calibration the following assays using ADVIA Centaur systems: Cortisol, Progesterone Testosterone.…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 519
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 (3)
- Lot codes/Exp Date: 91005A42 May 9
- 2016
- 53698A42 May 9
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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