Roche Recalls COBAS INTEGRA 400 Analyzer Software Due to Diagnostic Issue
Roche Molecular Systems is recalling 855 COBAS INTEGRA 400/400 plus systems due to a device-associated diagnostic software issue.
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 agency classification is Class II, and the source text does not report any illnesses, injuries, or specific high-risk hazards, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Roche Molecular Systems, Inc. is recalling 855 units of the COBAS INTEGRA 400/400 plus system, specifically software version 3.4. This fully automated, computerized chemistry analyzer is intended for the in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
The recall was initiated because the manufacturer became aware of a device-associated diagnostic software issue. The affected units were distributed nationwide.
The source text does not specify the exact nature of the software defect or provide instructions for consumers or healthcare facilities on how to proceed. Users of this equipment should contact Roche Molecular Systems, Inc. for further details regarding the recall and necessary corrective actions.
The recalled product
- Product
- The COBAS INTEGRA 400/400 plus system (software version 3.4) is a fully automated, computerized chemistry analyzer. It is intended for in vitro quantitative or qualitative determination of a wide range of analytes in various body fluids.
- Manufacturer
- Roche Molecular Systems, Inc.
- Hazard
- Affected units
- 855
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)
- Device-associated diagnostic software
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Roche Molecular Systems, 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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