Roche OMNI S6 Analyzer Software Defect Recalled by FDA
Roche Diagnostics is recalling 1,026 OMNI S6 analyzers because a software defect prevents scheduled AutoQC measurements from starting.
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, and the source text does not report any illnesses, injuries, or hospitalizations, 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 S6 system, catalog numbers 3337154001 and 3337154692. The recall was initiated because the software responsible for starting scheduled AutoQC measurements (the scheduler) will not activate.
The affected devices are fully automated critical care analyzers intended for the measurement of various blood and serum parameters, including pH, PCO2, PO2, sodium, potassium, and glucose. The distribution pattern for these units is nationwide in the USA.
No specific instructions for consumers or healthcare providers are provided in the source text regarding immediate actions to take, such as stopping use or contacting a representative. The recall is classified as Class II by the FDA.
The recalled product
- Product
- cobas b 221<6>Roche OMNI S6 system; Catalog numbers: 3337154001 and 3337154692 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…
- Manufacturer
- Roche Diagnostics Corporation
- Hazard
- 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)
- Catalog numbers: 3337154001 and 3337154692 UDI: 04015630018345
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 →- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- HighTandem t:slim iOS App Recall Due to CGM Pairing Failure
FDA (Devices) · 2026-10-07
- ModerateUnited Imaging uCT 550 CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- HighRoche OMNI S Cassette Recall for Incorrect Urea Measurement Results
FDA (Devices) · 2016-12-07
- ModerateRoche Omni Micro-electrode Recall for Inconsistent Reference Values
FDA (Devices) · 2014-10-22
- ModerateRoche Cobas b 221 S2 Fluid Pack Recall for Transponder Error
FDA (Devices) · 2015-08-12
- HighRoche Omni Micro-electrode Recalled for Potential Leakage and Erroneous Results
FDA (Devices) · 2014-04-09
- HighRoche Recalls 30 Cobas b 123 POC Systems for Quality Control Issue
FDA (Devices) · 2017-02-01
- HighRoche cobas b 123 Fluid Pack Recall for Low PO2 Results
FDA (Devices) · 2015-09-02