Abbott Alinity i 25-OH Vitamin D Reagent Kit Recall for Manufacturing Defect
Abbott is recalling specific lots of Alinity i 25-OH Vitamin D Reagent Kits due to a manufacturing issue that may damage bottle necks and cause instrument failure.
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 describes a mechanical defect causing instrument failure rather than a direct health hazard or reported injury, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Abbott Ireland Diagnostics Division is recalling 760 units of the Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532. The recall affects specific lots distributed to facilities in Arkansas, Florida, Georgia, Maryland, Oklahoma, and Virginia.
The recall is due to a manufacturing issue that can result in damage to the bottle neck of some reagent cartridges. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.
Facilities that have received these products should stop using the affected lots and contact Abbott for further instructions.
The recalled product
- Product
- Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
- Manufacturer
- Abbott Ireland Diagnostics Division
- Hazard
- Affected units
- 760
Distribution
Part of a larger recall action
This product is one of 6 recalled by Abbott Ireland Diagnostics Division 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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