Roche OMNI S4 Analyzer Recalled for Software Scheduler Failure
Roche Diagnostics is recalling 1,026 OMNI S4 analyzers because a software defect prevents the AutoQC scheduler from activating.
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 defect involves a software failure in the quality control scheduler rather than a direct, immediate physical hazard or reported injury, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Roche Diagnostics Corporation is recalling 1,026 units of the Cobas b 221 and Roche OMNI S4 systems, identified by catalog numbers 3337138001 and 3337138692. These are fully automated critical care analyzers used to measure various blood and serum parameters, including pH, PCO2, PO2, and electrolytes.
The recall is due to a software defect where the scheduler responsible for starting scheduled AutoQC measurements will not activate. This issue affects the automated quality control process of the devices.
The affected products were distributed nationwide in the United States. Users of these devices should contact Roche Diagnostics Corporation for further instructions on how to address the software issue.
The recalled product
- Product
- Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 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)
- Catalog numbers: 3337138001 and 3337138692 UDI: 04015630018321
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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