Roche Omni S2 Analyzer Recall Due to Software Failure
Roche Diagnostics is recalling 1,026 Omni S2 analyzers because a software defect prevents scheduled quality control measurements from starting.
What this means for you
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, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a software defect preventing quality control, which is a theoretical risk of harm rather than a reported injury, fitting the criteria for a moderate severity score.
Plain-English summary
Roche Diagnostics Corporation is recalling 1,026 units of the cobas b 221 Roche OMNI S2 system, catalog numbers 3337111001 and 3337111692. The recall was initiated because the software responsible for starting scheduled AutoQC measurements (the scheduler) will not activate. This defect prevents the automated quality control process from running as intended.
The affected devices are fully automated critical care analyzers used to measure various blood and fluid parameters, including pH, PCO2, PO2, sodium, potassium, and glucose. The recall covers units distributed nationwide in the United States. The UDI for the affected products is 04015630018307.
Healthcare facilities and users of these analyzers should contact Roche Diagnostics Corporation for instructions on how to address the software issue. The recall is classified as Class II by the FDA, indicating a situation where use of the product could, in some cases, cause temporary or medically reversible health consequences.
The recalled product
- Product
- cobas b 221<2>Roche OMNI S2 system catalog numbers: 3337111001 and 3337111692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit,
- Manufacturer
- Roche Diagnostics Corporation
- Affected units
- 1,026
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)
- 3337111001 and 3337111692 UDI: 04015630018307
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Roche Diagnostics Corporation 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 4 products in this recall →Related recalls
Same manufacturer · Roche Diagnostics Corporation
See all →- ModerateRoche Tina-quant lgA Gen.2 Assay Recalled Due to Reagent Contamination
FDA (Devices) · 2019-07-24
- LowRoche cobas p 701 Post-Analytical Units Recalled for Loose Flap
FDA (Devices) · 2019-07-10
- LowRoche cobas p 501 Post-Analytical Units Recalled for Loose Flap
FDA (Devices) · 2019-07-10
- HighRoche Cobas infinity Software Recall for Missing Quality Control Alarms
FDA (Devices) · 2019-05-29
- SevereRoche Recalls cobas e 801 Immunoassay Analyzers Due to Signal Drops
FDA (Devices) · 2019-05-08
Same hazard · software defect
See all →- HighMidmark IQecg Digital ECG Software Recall for Inaccurate Waveforms
FDA (Devices) · 2026-09-02
- HighMidmark Digital ECG Software Recall for Incorrect Waveform Display
FDA (Devices) · 2026-09-02
- ModerateEndoFLIP System Recall Due to Incorrect Catheter Expiration Flags
FDA (Devices) · 2026-08-26
- HighBeckman Coulter DxC 500i Analyzer Modules Recalled for Software Defect
FDA (Devices) · 2026-08-26
- HighMitsubishi Recalls Outlander Models for Rearview Camera Software Defect
NHTSA · 2026-08-25