Roche LightCycler 1.2 Diagnostic Software Recalled for Device-Associated Issue
Roche Molecular Systems is recalling LightCycler 1.2 software due to a device-associated diagnostic software issue. The recall covers 3,772 units distributed nationwide.
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 recall is classified as FDA Class II, but the source text does not report any hospitalizations, 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 the LightCycler 1.2 (software version 3.5), a Rapid PCR analyzer with real-time detection and quantification capabilities. The recall involves 3,772 units that were distributed nationwide.
The recall was initiated because the company became aware of a device-associated diagnostic software issue. The source text does not specify the exact nature of the software defect, the potential impact on diagnostic results, or any reported injuries or illnesses.
Users of the LightCycler 1.2 software should contact Roche Molecular Systems for further instructions on how to address the software issue. No specific corrective actions, such as software updates or device replacements, are detailed in the provided source text.
The recalled product
- Product
- LightCycler 1.2 (software version 3.5) is a Rapid PCR analyzer with real-time detection and/or quantification of a target NA (nucleic acid), as well as post-PCR analysis of the amplified NA by melting curve analysis with corresponding assays.
- Manufacturer
- Roche Molecular Systems, Inc.
- Hazard
- Affected units
- 3,772
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.
See all 10 products in this recall →Related recalls
Same manufacturer · Roche Molecular Systems, Inc.
See all →- HighRoche cobas Influenza Test Recall Due to False Negative Results
FDA (Devices) · 2023-02-15
- HighRoche Influenza A/B and RSV Test Kit Recalled for False Negative Results
FDA (Devices) · 2023-02-15
- HighRoche cobas Flu/COVID assay recalled for false negative influenza results
FDA (Devices) · 2023-02-15
- HighMedical Device Recall: Roche cobas 5800 False Results Due to Baseline Anomalies
FDA (Devices) · 2022-10-26
- ModerateCobas Liat respiratory virus analyzer units recalled for false Influenza B results
FDA (Devices) · 2022-04-06
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateRoche cobas b 221 AutoQC Module Recall for Software Failure
FDA (Devices) · 2018-05-09
- ModerateRoche Recalls LightMix Zika rRT-PCR Test Due to False Positive Risk
FDA (Devices) · 2016-12-21
- ModerateRoche Omni S2 Analyzer Recall Due to Software Failure
FDA (Devices) · 2018-05-09
- ModerateRoche OMNI S6 Analyzer Software Defect Recalled by FDA
FDA (Devices) · 2018-05-09
- ModerateRoche Recalls cobas Liat Analyzers Due to Incorrect LED Components
FDA (Devices) · 2015-09-09
- HighRoche cobas z 480 Analyzer Recalled for Dirty Lens Risk
FDA (Devices) · 2021-01-20