Siemens ADVIA Centaur Calibrator A Kits Recalled for FT4 Bias
Siemens recalls ADVIA Centaur Calibrator A kits due to negative bias in FT4 assays and potential calibration failures 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, which typically corresponds to a moderate severity level involving temporary or medically reversible adverse health consequences, without reports of serious injury or death.
Plain-English summary
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems Calibrator A Kits. The recall involves specific lot numbers ending in 90, including 07995A90, 08451A90, 16035A90, 32420A90, 43871A90, 59675A90, and 62739A90, with an expiration date of July 24, 2017. A total of 9,664 kits were distributed nationwide and to numerous international locations.
The recall was initiated because Siemens confirmed a negative bias for the FT4 assay when using these specific calibrator kits 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 kits 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 ADVIA Centaur Systems FT3, T3, T4, and TUp assays. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
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
- 9,664
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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