Roche Tina-quant lgA Gen.2 Assay Recalled Due to Reagent Contamination
Roche Diagnostics is recalling Tina-quant lgA Gen.2 assays due to reagent contamination causing calibration and quality control failures.
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 describes technical calibration and quality control failures without reporting any patient injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Roche Diagnostics Corporation is recalling 8 units of the Tina-quant lgA Gen.2 immunoturbidimetric assay, specifically Lot 368756. The product is used to measure antigen/antibody complexes in samples.
The recall was initiated because the R1 reagent was contaminated with R3 reagent. This contamination resulted in atypical reaction kinetics, leading to calibration failures (Std.E, Sens.E) and quality control failures (Dup.E).
The affected products were distributed to laboratories in Alabama, Indiana, and Kentucky. Users of this specific lot should stop using the product and contact the manufacturer for instructions.
The recalled product
- Product
- The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.
- Manufacturer
- Roche Diagnostics Corporation
- Affected units
- 8
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 368756
Distribution
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