Roche cobas c513 Analyzer Recalled for High Pressure Solenoid Valve Quality Issue
Roche Diagnostics is recalling two cobas c513 Analyzers due to a quality issue with high pressure solenoid valves.
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 injuries, illnesses, or specific hazards beyond the quality issue, fitting the criteria for a moderate severity score.
Plain-English summary
Roche Diagnostics Operations, Inc. is recalling two units of the cobas c513 Analyzer. The recall is due to a quality issue with the high pressure solenoid valves.
The affected units have serial numbers 1731-08 and 1722-03. These devices were distributed to facilities in New York, Montana, Hawaii, Indiana, Maryland, Texas, Ohio, Kansas, Kentucky, California, Florida, Oregon, Louisiana, Missouri, and Alaska.
The source text does not specify the exact corrective action consumers or facilities should take, nor does it report any injuries or illnesses associated with this defect.
The recalled product
- Product
- cobas c513 Analyzer
- Manufacturer
- Roche Diagnostics Operations, Inc.
- Hazard
- Affected units
- 2
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 (2)
- Serial # :1731-08
- 1722-03
Distribution
Part of a larger recall action
This product is one of 3 recalled by Roche Diagnostics Operations, 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.
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