Roche Tina-quant sTfR Assay Recalled for Rheumatoid Factor Interference
Roche Diagnostics is recalling Tina-quant Soluble Transferrin Receptor (sTfR) assays due to updated claims regarding rheumatoid factor interference.
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 source text does not report any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling the Tina-quant Soluble Transferrin Receptor (STFR) Assays, catalog number 05950821190. The recall involves 1,086 units distributed nationwide. The product is used in conjunction with the cobas c 701 and 702 Analyzer/Module.
The recall is being conducted to address updated claims regarding interference from rheumatoid factors in the assay. The source text identifies this as a Class II recall by the U.S. Food and Drug Administration.
Healthcare facilities and laboratories should stop using the affected assays and contact Roche Diagnostics for further instructions or replacement.
The recalled product
- Product
- cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Hazard
- Affected units
- 1,086
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)
- All serial numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Roche Diagnostics Operations, 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 · Roche Diagnostics Operations, Inc.
See all →- HighRoche cobas analyzer may repeat previous results for spline calibrated assays
FDA (Devices) · 2026-03-11
- HighThyroid receptor immunoassay recalled over variable results across instrument platforms
FDA (Devices) · 2026-01-14
- HighMedical Device Homocysteine Test Assay Recalled for Calibration Defects
FDA (Devices) · 2024-11-27
- HighRoche Creatine Kinase test reagents recalled for calibration errors
FDA (Devices) · 2024-10-02
- HighRoche Tina-quant D-Dimer Test System Recalled for Inaccurate Results
FDA (Devices) · 2023-11-29
Same hazard · interference
See all →- ModerateOrtho Clinical Diagnostics Recalls VITROS XT Chemistry Products ALB-TP Slides
FDA (Devices) · 2021-01-20
- HighBeckman Coulter Total Bilirubin Reagent Recalled for Acetaminophen Interference
FDA (Devices) · 2020-03-11
- HighRoche Tina-quant sTfR Assay Recalled for Rheumatoid Factor Interference
FDA (Devices) · 2019-10-16
- ModerateTosoh AIA-PACK B12 Recalled Due to Potential Fluorescein Interference
FDA (Devices) · 2019-01-02
- HighTosoh ST-AIA PACK CK-MB Recalled Due to Strensiq Interference
FDA (Devices) · 2018-06-13
Similar recalls
- SevereRoche Tina-quant IgM Gen.2 Recalled for Endogenous Interference
FDA (Devices) · 2019-04-24
- ModerateRoche Recalls Tina-quant C-Reactive Protein Gen.3 Reagents Due to Cross-Contamination
FDA (Devices) · 2020-12-23
- LowRoche Recalls Tina-quant Complement C4 Reagents Due to Quality Issues
FDA (Devices) · 2020-10-21
- HighRoche Tina-Quant CRP Latex Test System Recalled for Low Results
FDA (Devices) · 2017-02-01
- ModerateLaboratory Reagent Recalled Due to Inaccurate Calibration Curves
FDA (Devices) · 2022-07-27
- HighRoche Tina-quant D-Dimer Test System Recalled for Inaccurate Results
FDA (Devices) · 2023-11-29