Siemens Recalls ADVIA Centaur TSH3 Ultra Ready Packs Due to Interference
Siemens Healthcare Diagnostics is recalling ADVIA Centaur TSH3 Ultra Ready Packs because samples containing fluorescein may interfere with assay results.
What this means for you
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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is potential assay interference rather than a direct physical injury or high-risk pathogen, fitting the Moderate criteria for low-risk contamination or labeling/functional errors without reported serious injury.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 22,770 kits of the ADVIA Centaur Systems TSH3 Ultra Ready Pack (Catalog Number: 06491072; Siemens Material Number: 10282378). The product is intended for in vitro diagnostic use in the quantitative determination of various assays on the ADVIA Centaur and ADVIA Centaur XP analyzers.
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 lots are identified by specific expiration dates: 17 April 2014, 17 June 2014, 01 August 2014, 30 September 2014, 18 November 2014, 21 January 2015, and 18 November 2014. The products were distributed worldwide, including nationwide in the United States and in numerous other countries. Users should stop using the affected kits and contact Siemens Healthcare Diagnostics for further instructions.
The recalled product
- Product
- ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Material Number: 10282378. 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
- 22,770
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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