Siemens ADVIA Centaur Tnl-Ultra Assay Recalled for Biotin Interference
Siemens Healthcare is recalling ADVIA Centaur Tnl-Ultra Assay kits because biotin in patient samples can alter test results by more than 10%.
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. The hazard involves potential diagnostic inaccuracy due to biotin interference, which is a significant quality issue but does not involve reported deaths, serious injuries, or high-risk pathogens like Listeria or E. coli.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling the ADVIA Centaur Tnl-Ultra Assay, an in-vitro diagnostic used to measure cardiac troponin I in serum or plasma. The recall covers specific catalog numbers and stock management numbers, with a total of 32,467 kits affected.
The recall was initiated because the assay exhibits a greater than 10% change in results when samples contain biotin levels up to 10 ng/mL (41 nmol/L). The product's Instructions for Use (IFU) state that specimens with up to 10 ng/mL of biotin may be affected by this interference.
The affected products were distributed worldwide, including nationwide in the United States and in numerous international locations. Healthcare facilities and laboratories that use these assays should stop using the affected kits and contact Siemens Healthcare for further instructions.
The recalled product
- Product
- Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determination of cardiac troponin For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA…
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
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)
- All in date lots
Distribution
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