Siemens ADVIA Centaur Calibrator 30 Recalled for Negative Bias
Siemens is recalling ADVIA Centaur Calibrator 30 kits because they cause negative bias in Estradiol tests on specific systems.
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, and the source text describes a calibration bias without reporting specific patient injuries or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur Calibrator 30 kits (2 pack, 6 pack, and Ref 2 pack) with specific lot numbers. The recall affects 5,992 units distributed in the US and outside the US (OUS).
The recall was initiated because Siemens confirmed a negative bias for ADVIA Centaur Enhanced Estradiol (eE2) tests when using Calibrator 30 kit lots ending in 21 (C3021) compared to lots ending in 20 (C3020). This issue affects the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems.
The affected lots are 00387A21, 16673A21, 36243A21, 00388A21, 15448A21, 51211A21, 20640A21, and 51024A21, all with an expiration date of 2018-03-08. Users should stop using these specific calibrator lots and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810, 10379811, 10697756.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 5,992
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 (8)
- Lot Numbers: 00387A21
- 16673A21
- 36243A21
- 00388A21
- 15448A21
- 51211A21
- 20640A21
- 51024A21. Expiration Date: 2018-03-08
Distribution
Distribution scope not specified by the agency.
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