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.
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, 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 →- 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
- ModerateSiemens Tricyclic Antidepressant Calibrator/Controls Recall Lot U2
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 →- HighMaquet Critical Care Recalls Y Sensor Modules for Electrical Safety Testing Omission
FDA (Devices) · 2026-08-26
- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighAngiodynamics Soft-Vu Angiographic Catheter Guidewire Blockage Risk
FDA (Devices) · 2026-04-29
- SevereGE Healthcare CARESTATION anesthesia systems ventilation malfunction recall
FDA (Devices) · 2025-05-07