Abbott Alinity i Estradiol Reagent Kit Recalled for Manufacturing Defect
Abbott is recalling 79 units of Alinity i Estradiol Reagent Kits due to a manufacturing issue that may cause bottle neck damage and 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 leading to instrument failure without reporting any patient injuries, illnesses, or deaths. This aligns with the 'Moderate' criteria for low-risk issues or voluntary precautionary recalls where harm has not been reported.
Plain-English summary
Abbott Ireland Diagnostics Division is recalling 79 units of Alinity i Estradiol Reagent Kits, List Number 07P5020. The recall is due to a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges.
If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument. The affected units were distributed to facilities in Arkansas, Florida, Georgia, Maryland, Oklahoma, and Virginia.
The source text does not specify specific actions for consumers or healthcare providers, such as stopping use or contacting the manufacturer, but the recall is initiated to address the potential for instrument failure.
The recalled product
- Product
- Alinity i Estradiol Reagent Kit, List Number 07P5020
- Manufacturer
- Abbott Ireland Diagnostics Division
- Hazard
- Affected units
- 79
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)
- UDI/Lot Numbers (01)00380740131159 (17)190317(10) 90193UI00 / 90193UI00
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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