Siemens Dimension Vista TSH Reagent Cartridge Recall for Incorrect Biotin Units
Siemens is recalling Dimension Vista TSH reagent cartridges because the instructions for use list incorrect units and interference levels for biotin.
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 involves a labeling/documentation error regarding biotin interference levels, which fits the criteria for minor labeling errors or low-risk contamination without reported injuries.
Plain-English summary
Siemens Healthcare Diagnostics, Inc. is recalling 19,927 units of the Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge. The recall involves specific lots including 16118BD, 16159BA, 16193BC, 16193BD, 16208AA, 16251BA, 16277BD, 16322BB, 17005BB, and 17023AC. The product was distributed throughout the United States, Canada, and numerous international locations.
The recall was initiated because the Non-Interfering Substances section of the current Instructions for Use (IFU) for the Dimension and Dimension Vista TSH reagent cartridges contains errors. Specifically, the concentrations for Biotin are listed with incorrect units and incorrectly state the level at which biotin does not interfere with the test results. This documentation error affects the Dimension TNI, Dimension Vista DIGXN, E2, FERR, PRL, and TSH reagents.
Healthcare facilities and laboratories that possess these specific reagent cartridges should stop using them and contact Siemens Healthcare Diagnostics for instructions on how to return the product. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
- Manufacturer
- Siemens Healthcare Diagnostics, Inc.
- Hazard
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 (9)
- Device Listing Number # D230089 Lot # 16118BD
- 16159BA
- 16193BC
- .16193BD
- 16208AA
- 16251BA 16277BD
- 16322BB
- 17005BB
- 17023AC
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 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 6 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 · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02