Abbott Recalls Alinity c Cuvette Segments Due to Seating Defect
Abbott is recalling Alinity c Cuvette Segments because individual cuvettes may seat lower than designed, potentially preventing the sample probe from making efficient contact with the cuvette bottom.
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, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a mechanical defect that may lead to inadequate sample dispense, which fits the criteria for a moderate severity recall involving a risk of harm where injury has not yet been reported or a voluntary precautionary recall.
Plain-English summary
Abbott GmbH & Co. KG is recalling Alinity c Cuvette Segments, List Number 04S47-01. The recall involves 19,184 units distributed nationwide in the United States and in numerous countries worldwide. The affected products are used on the Alinity c system processing module, a fully automated chemistry analyzer.
The recall is being issued because individual cuvettes within the segment may become seated lower than the designed height. This defect may result in inadequate dispense into specific cuvettes because the sample probe may be unable to make efficient contact with the cuvette bottom.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the defect.
The recalled product
- Product
- Alinity c Cuvette Segments, List Number 04S47-01 Product Usage: The Alinity c Cuvettes are used on the Alinity c system processing module. The Alinity c processing module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and auto
- Manufacturer
- Abbott Gmbh & Co. KG
- Affected units
- 19,184
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)
- All serial numbers
Distribution
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