Siemens ADVIA Centaur Calibrator A Kits Recalled for FT4 Bias
Siemens is recalling specific Calibrator A kits due to confirmed negative bias and potential calibration failures for the FT4 assay on certain ADVIA Centaur 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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a performance defect (negative bias/calibration failure) rather than a direct physical safety risk, fitting the Moderate category for low-risk contamination or performance issues without reported harm.
Plain-English summary
Siemens Healthcare Diagnostics is recalling 194 units of ADVIA Centaur Systems Calibrator A Kits. The affected lots are 08722A90, 27210A90, and 43429A90, all with an expiration date of July 24, 2017. These kits were distributed nationwide and to numerous international locations.
The recall was initiated because Siemens confirmed a negative bias for the Free T4 (FT4) assay when using these specific calibrator lots on the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT Systems. Additionally, there is a potential for calibration failures due to above-limit calibrator RLU %CVs when using these lots with the FT4 assay. The performance of the FT4 assay on the ADVIA Centaur CP System is not affected by this issue.
Customers may continue to use the affected Calibrator A kit lots for the FT3, T3, T4, and TUp assays on the ADVIA Centaur Systems. The recall is limited to the FT4 assay on the specific system models mentioned.
The recalled product
- Product
- Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 04800735, SMN 10285904 (6 pack) Cat No. 04800840, SMN 10285905 (6 pack - REF)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 194
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 (1)
- Lot Numbers: 08722A90 27210A90 43429A90 Exp. Date: 2017/07/24
Distribution
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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