Siemens ADVIA Centaur TSH3-Ultra Assay Recalled for Analyzer Compatibility Issues
Siemens is recalling specific lots of ADVIA Centaur TSH3-Ultra assays because they may cause reduced dilution recovery or inoperability when used with Multi-Diluent 15 on certain analyzers.
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 functional compatibility issue (reduced dilution recovery or inoperability) rather than a direct health risk like infection or acute injury, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling specific lots of the ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra) assay. The affected catalog numbers are 06491072, 06491080, and 04862625. The recall involves 74,215 units distributed across 27 U.S. states, Puerto Rico, and multiple international countries.
The recall is being issued because, in certain scenarios, the ADVIA Centaur CP, XP, and XPT immunoassay analyzers may exhibit reduced dilution recovery or become inoperable when used with Multi-Diluent 15 and certain lots of BNP and TSH3RUL Assays. The affected lots are identified by lot numbers ending in 298 and 301.
Healthcare facilities and laboratories should stop using the affected lots and contact Siemens Healthcare Diagnostics for instructions on returning the product. This recall addresses a compatibility issue between the assay and specific analyzer configurations rather than a direct patient safety hazard such as infection or acute injury.
The recalled product
- Product
- ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests), 06491080 (500 tests), 04862625 (2500 tests)
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Affected units
- 74,215
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)
- Lot Numbers ending in: 298 and 301
Distribution
Part of a larger recall action
This product is one of 2 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Siemens Healthcare Diagnostics, Inc.
See all →- HighSiemens Atellica CH C-Reactive Protein Reagent Recalled for Falsely Elevated Results
FDA (Devices) · 2026-10-07
- SevereSiemens Recalls Emit 2000 Quinidine Assay Due to Precision Issues
FDA (Devices) · 2026-08-26
- SevereSiemens Quinidine Assay Recalled for Precision Errors
FDA (Devices) · 2026-08-26
- HighSiemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
FDA (Devices) · 2026-08-12
- LowSyva Emit Disopyramide Enzyme Immunoassay Calibrator Recalled for Sodium Azide Concentration
FDA (Devices) · 2026-08-12
Same hazard · functional defect
See all →- ModerateSunMed Tracheal Tube Recalled Due to Suction Catheter Passage Issues
FDA (Devices) · 2026-09-23
- ModerateWilson-Cook Recalls Hemospray Endoscopic Hemostat Due to Adherence Issues
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Impella Optical Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- SevereAbiomed Recalls Automated Impella Controllers Due to Purge Sensor Defect
FDA (Devices) · 2026-09-23
- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
Similar recalls
- ModerateSiemens ADVIA Centaur TSH3 Ultra Reagent Recall Due to Interference
FDA (Devices) · 2014-06-04
- ModerateSiemens ADVIA Centaur TSH3 Ultra Recalled for Fluorescein Interference
FDA (Devices) · 2014-06-04
- ModerateSiemens Recalls ADVIA Centaur TSH3 Ultra Ready Packs Due to Interference
FDA (Devices) · 2014-06-04
- HighSiemens ADVIA Centaur TSH3 Ultra ReadyPack Recalled for Rare TSH Variant Detection Failure
FDA (Devices) · 2013-08-14
- ModerateSiemens ADVIA Centaur Multi-Diluent 1 Recalled for Decreased Dilution Recovery
FDA (Devices) · 2012-09-12
- ModerateSiemens Recalls ADVIA Centaur T3 Kits Due to Barcode Scanning Issue
FDA (Devices) · 2018-03-07