Roche Tina-quant sTfR Assay Recalled for Rheumatoid Factor Interference
Roche Diagnostics is recalling Tina-quant sTfR assays due to updated claims regarding rheumatoid factor interference.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, which typically corresponds to a High severity score (3) when no specific hospitalizations or severe injuries are reported in the source text.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling the Tina-quant Soluble Transferrin Receptor (STFR) Assays, catalog number 20763454122. The recall involves 6,494 units distributed nationwide. The affected products are used with the cobas c 311, cobas c 501, cobas c 502, and COBAS INTEGRA 400 plus Analyzer/Module.
The recall is being conducted to address updated claims regarding interference from rheumatoid factors in the assay. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Healthcare facilities and laboratories should stop using the affected Tina-quant sTfR Assays and contact Roche Diagnostics for further instructions on the recall process.
The recalled product
- Product
- cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Hazard
- Affected units
- 6,494
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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