Siemens ADVIA Centaur TSH3 Ultra Recalled for Fluorescein Interference
Siemens Healthcare Diagnostics is recalling ADVIA Centaur Systems TSH3 Ultra kits because fluorescein samples may interfere with test results.
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 hazard is a potential analytical interference rather than a direct physical injury or high-risk pathogen, fitting the criteria for moderate severity involving low-risk contamination or labeling/functional issues without reported illness.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 8,052 kits of ADVIA Centaur Systems TSH3 Ultra tests. The affected kits are intended for in vitro diagnostic use in the quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers. The recall covers specific kit lots with expiration dates ranging from April 2014 to January 2015.
The recall was initiated because samples containing fluorescein may show interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D, and the ADVIA Centaur BRAHMS Procalcitonin assays. This interference could potentially affect the accuracy of the diagnostic results.
The affected products were distributed worldwide, including nationwide in the United States and in numerous other countries. Healthcare facilities and laboratories that possess these specific kits should stop using them and contact Siemens Healthcare Diagnostics for instructions on return or replacement.
The recalled product
- Product
- ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material Number (SMN) : 10361944. Intended for the invitro diagnostic use in quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
- Manufacturer
- Siemens Healthcare Diagnostics, Inc
- Hazard
- Affected units
- 8,052
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 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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