Roche Cobas Infinity Software Error May Allow Unreliable Lab Results
Roche is recalling 76 licenses of Cobas Infinity software due to an error that may remove quality flags, allowing unreliable test results to be reported.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device software) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling 76 licenses of the Cobas Infinity calculator/data processing module, catalog number 07154003001. The recall covers all versions from 3.00.00 onwards distributed nationwide in the United States.
The recall is due to a software error that can unintentionally remove the serum-indices flag. This flag is normally used to hold results for manual review when sample quality issues, such as hemolysis, icterus, or lipemia, are detected. The error may allow samples of poor quality to return unreliable or incorrect test results that are reported to health care providers or patients without the proper disclaimer regarding sample quality.
Health care providers and laboratories using the affected software should contact Roche for instructions on how to address the software error and ensure proper review of test results.
The recalled product
- Product
- A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data Catalog Number: 07154003001
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Affected units
- 76
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)
- All versions from cobas infinity version 3.00.00 onwards
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Roche Diagnostics Operations, Inc.
See all →- HighRoche cobas analyzer may repeat previous results for spline calibrated assays
FDA (Devices) · 2026-03-11
- HighThyroid receptor immunoassay recalled over variable results across instrument platforms
FDA (Devices) · 2026-01-14
- HighMedical Device Homocysteine Test Assay Recalled for Calibration Defects
FDA (Devices) · 2024-11-27
- HighRoche Creatine Kinase test reagents recalled for calibration errors
FDA (Devices) · 2024-10-02
- HighRoche Tina-quant D-Dimer Test System Recalled for Inaccurate Results
FDA (Devices) · 2023-11-29
Same hazard · software error
See all →- HighQuantum Rehab R-TRAK Powered Wheelchair Controller Recalled Due to Software Issue
FDA (Devices) · 2026-08-12
- HighDASH Rapid PCR Instrument Recalled Due to Software Issue Causing False Co-infection Results
FDA (Devices) · 2026-08-12
- HighQuantum Outback Powered Wheelchair Controller Recalled Due to Unexpected Braking Risk
FDA (Devices) · 2026-08-12
- HighREMISOL Advance Software Version 2.5 Recalled for Incorrect Test Result Reporting
FDA (Devices) · 2026-08-12
- HighQuantum Rehab Q6 Edge 3 Powered Wheelchair Controller Recalled for Unexpected Braking
FDA (Devices) · 2026-08-12