Roche Recalls Tina-quant Complement C4 Reagents Due to Quality Issues
Roche Diagnostics is recalling 180 units of Tina-quant Complement C4 reagents due to cross-contamination causing invalid calibrations.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as unlikely to cause adverse health consequences, typically resulting in a score of 1 or 2.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 180 units of Tina-quant Complement C4 ver.2, Catalog 05991994190, lot 36870301. The products were distributed domestically nationwide.
The recall was initiated after Roche confirmed customer complaints regarding low quality control recovery and invalid calibrations. The company identified that a yellow discoloration was observed, which resulted from cross-contamination between the R1 and R3 reagents.
This recall is classified as Class III by the FDA, indicating that use of or exposure to the product is not likely to cause adverse health consequences. Users should stop using the affected lot and contact Roche Diagnostics for further instructions.
The recalled product
- Product
- Tina-quant Complement C4 ver.2, Catalog 05991994190
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 180
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 36870301
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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