Roche Cobas 8000 Software Recall for Incorrect Immunoassay Results
Roche Diagnostics is recalling software for the cobas e 602 module because it may produce incorrect test results under specific conditions.
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 medical device that may produce incorrect diagnostic results, which poses a risk of harm to patients through misdiagnosis or inappropriate treatment, even though no specific injuries are reported in the text.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling software versions 03-01, 02, 03, and 04 for the Cobas 8000 modular analyzer series, specifically affecting the cobas e 602 module. The recall involves 72 units distributed nationwide in the United States.
The recall is due to a potential issue where the use of Diluent Multiassay for autodilution of certain assays, instead of Diluent Universal, may cause incorrect results. This risk occurs only if specific conditions are met simultaneously, including the registration of more than 2,000 reagent kits or diluents on the cobas e 602 modules within one system core and the presence of two different diluents.
Healthcare facilities using the affected software should contact Roche Diagnostics for instructions on how to resolve the issue. The product is a fully automated immunoassay analyzer intended for the in-vitro quantitative and qualitative determination of analytes in body fluids.
The recalled product
- Product
- Cobas¿ 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Hazard
- Affected units
- 72
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 (20)
- Part Number 05990378001 Serial Numbers 1017-06
- 1021-03
- 1021-05
- 1142-09
- 1145-10
- 1140-01
- 1125-07
- 1128-02
- 1146-01
- 1146-02
- 1146-03
- 1171-10
- 1169-06
- 1169-08
- 1169-09
- 1172-09
- 1156-01
- 1156-02
- 1156-09
- 1160-04
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 · incorrect results
See all →- CriticalLibre 3 Plus sensors, REF 78769-01, recalled over carbon build up
FDA (Devices) · 2026-01-21
- CriticalGlucose monitoring sensors recalled over carbon build up causing low readings
FDA (Devices) · 2026-01-21
- CriticalLibre 3 Plus sensors recalled over carbon build up causing low readings
FDA (Devices) · 2026-01-21
- CriticalLibre 3 Plus sensors recalled in a second lot over carbon build up
FDA (Devices) · 2026-01-21
- HighSkin cancer aid recalled because it may not meet specifications
FDA (Devices) · 2025-12-03