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.
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 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
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