Roche Tina-Quant Myoglobin Gen. 2 Assay Recalled for QC Imprecision
Roche is recalling Tina-Quant Myoglobin Gen. 2 assays due to signal drops causing calibration failures and QC imprecision on specific 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 source text does not report any hospitalizations, injuries, or illnesses. The hazard is limited to analytical imprecision and calibration failures, fitting the criteria for a moderate severity score.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling the Tina-Quant Myoglobin Gen. 2 Tests system, an immuno-turbidimetric assay used for the quantitative in vitro determination of myoglobin in human serum and plasma. The recall affects 4,309 units distributed nationwide, specifically lot number 349860 and onward, used on cobas c311, c501, and c502 automated clinical chemistry analyzers.
Internal investigations confirmed customer complaints regarding quality control (QC) imprecision and calibration failures. These issues were traced to a drop in signal in the reaction kinetics caused by an adjacent cell mixing effect. This disturbance decreased sample recovery and resulted in discrepancies of up to -30% in calibration, QC, and patient samples.
As a long-term solution, the firm will implement extra wash cycles into the Special Wash Requirements method sheets and the cobas e-file. Users of the cobas c501 and c502 modules are directed to run the assay independently in batch mode with a maximum of 39 samples per run. Additionally, application settings will be changed to prevent the use of adjacent cuvettes, a change that will be communicated at a later date.
The recalled product
- Product
- The Tina-Quant Myoglobin Gen. 2 Tests system is an immuno-turbidimetric assay for the quantitative in vitro determination of myoglobin in human serum and plasma on Roche automated clinical chemistry analyzers
- Manufacturer
- Roche Diagnostics Operations, Inc.
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: 349860 and onward
Distribution
Distributed nationwide across the United States.
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