Roche Recalls Tina-quant C-Reactive Protein Gen.3 Reagents Due to Cross-Contamination
Roche is recalling Tina-quant C-Reactive Protein Gen.3 reagents due to cross-contamination causing invalid calibrations and low quality control recovery.
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 or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 699 units of Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190. The product is used for the in vitro quantitative determination of C-Reactive Protein (CRP) in human serum and plasma on Roche automated clinical chemistry analyzers.
The recall was initiated after Roche confirmed customer complaints regarding low quality control (QC) recovery and invalid calibrations for the product when used on cobas c701 and 702 modules. The issues were attributed to a yellow discoloration resulting from cross-contamination between the R1 and R3 reagents.
The affected units were distributed nationwide in the United States, including in the states of AL, CA, FL, GA, HI, IA, IL, IN, KY, MA, MD, MI, MN, MO, NJ, NY, OH, PA, SC, TN, TX, and VA. The specific lot number is 42402301. Users should stop using the affected product and contact the manufacturer for further instructions.
The recalled product
- Product
- Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 699
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)
- CRPL3 - lot 42402301
Distribution
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 · cross contamination
See all →- CriticalCetirizine Hydrochloride Tablets Recalled Due to Cross Contamination with Ranitidine
FDA (Drugs) · 2026-07-29
- ModeratePrimidone tablets recalled over potential acemetacin cross-contamination at API manufacturer
FDA (Drugs) · 2026-06-17
- HighFly By Jing creamy sesame noodles may contain undeclared peanut
FDA (Food) · 2026-06-03
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets 50 mg Recalled for API Cross-Contamination
FDA (Drugs) · 2026-05-27