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.
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, 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, hematocrit,
- 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.
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