Siemens Recalls ADVIA Centaur T3 Kits Due to Barcode Scanning Issue
Siemens is recalling ADVIA Centaur T3 kits because a barcode scanning issue on the ADVIA Centaur XPT system may affect specific lots.
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 describes a technical barcode scanning issue without reporting any illnesses, injuries, or adverse health consequences, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur T3 kits. The product is used for in vitro diagnostic testing to measure triiodothyronine (T3) in serum for the diagnosis and treatment of thyroid disease.
The recall is due to an identified issue when scanning the 20 barcode for the Master Curve Card (MCC) with ADVIA Centaur systems. This issue specifically affects T3 kit lots ending in 198 when used on the ADVIA Centaur XPT system.
The recall involves 33,298 units distributed worldwide, including in the United States. Users of the affected kits should contact Siemens Healthcare Diagnostics, Inc. for further instructions on how to proceed.
The recalled product
- Product
- ADVIA Centaur¿ T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of triiodothyronine (T3) in serum using the ADVIA Centaur, ADVIA Centaur XP, and ADVIA Centaur XPT systems. Measurements of triiodothyronine are used in the diagnosis and…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Affected units
- 33,298
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)
- x
Distribution
Distribution scope not specified by the agency.
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