Roche Recalls Albumin Gen.2 Reagents Due to Cross-Contamination
Roche Diagnostics is recalling Albumin Gen.2 reagents due to cross-contamination causing low quality recovery and 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 agency classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a quality control defect resulting in invalid test results rather than a direct physical hazard to the patient.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 11,963 units of Albumin Gen.2, Catalog 05166861190. The affected lots are 43031001 and 43718901. The product was distributed domestically nationwide.
The recall was initiated after Roche confirmed customer complaints regarding low quality control recovery and invalid calibrations. The company identified a yellow discoloration in the product, which is the result of cross-contamination between the R1 and R3 reagents.
Users of this product should stop using the affected lots and contact Roche Diagnostics for further instructions or a replacement.
The recalled product
- Product
- Albumin Gen.2, Catalog 05166861190
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 11,963
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 (2)
- lots 43031001
- 43718901
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.
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