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.
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 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
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