Abbott Recalls Alinity i Total Beta-hCG Reagent Kit Due to Manufacturing Defect
Abbott is recalling 27 units of the Alinity i Total Beta-hCG Reagent Kit because a manufacturing issue may damage bottle necks, causing reagent loading failures on the instrument.
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 failure (reagent loading failure) without reporting any patient injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary recalls where no harm has been reported.
Plain-English summary
Abbott Ireland Diagnostics Division is recalling 27 units of the Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121. The recall is due to a manufacturing issue that can result in damage to the 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 specific lot numbers are identified by UDI/Lot Numbers (01)00380740160616 (17)190807(10)92056UI00 / 92056UI00.
Healthcare facilities should check their inventory for the affected lot numbers and stop using these reagent kits. Users should contact Abbott for further instructions on how to return or dispose of the affected units.
The recalled product
- Product
- Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
- Manufacturer
- Abbott Ireland Diagnostics Division
- Hazard
- Affected units
- 27
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)00380740160616 (17)190807(10)92056UI00 / 92056UI00
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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