Siemens ADVIA Centaur TSH3 Ultra Reagent Recall Due to Interference
Siemens is recalling ADVIA Centaur TSH3 Ultra reagent kits because samples containing fluorescein may interfere with test 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, and the hazard involves potential test interference rather than direct physical injury or reported illness, fitting the criteria for a moderate severity score.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling ADVIA Centaur Systems TSH3 Ultra, Ready Pack, 500 test kits. The recall involves 155,345 kits distributed worldwide, including the United States and numerous international locations.
The recall is due to potential interference with the ADVIA Centaur Systems TSH3 Ultra, Vitamin D, and ADVIA Centaur BRAHMS Procalcitonin assays when samples containing fluorescein are tested. This interference may affect the accuracy of quantitative determinations on the ADVIA Centaur and ADVIA Centaur XP analyzers.
Affected lots are identified by specific expiration dates: 17 April 2014, 17 June 2014, 01 August 2014, 30 September 2014, 18 November 2014, and 21 January 2015. Users should check their inventory for these specific lot codes and expiration dates.
The recalled product
- Product
- ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens Material Number: 10282379. 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
- 155,345
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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