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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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.
See all 6 products in this recall →Related recalls
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