Abbott Alinity i TSH Reagent Kit Recalled for Manufacturing Defect
Abbott is recalling Alinity i TSH Reagent Kits due to a manufacturing issue that may damage bottle necks, potentially 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 defect causing instrument loading failure without reporting any patient injuries, illnesses, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Abbott Ireland Diagnostics Division is recalling 678 units of the Alinity i TSH Reagent Kit, List Number 07P4830. The recall is due to a manufacturing issue that can result in damage to the bottle neck in some of the reagent cartridges found in the affected lots.
If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument. The affected lots are identified by the following UDI/Lot Numbers: (01)00380740131159 (17)190710(10)90061UI00 / 90061UI00, (01)00380740131159 (17) 190827(10) 91526UI00 / 91526UI00, and (01)00380740131159 (17)190924(10)92291UI00 / 92291UI00.
The product was distributed to facilities in Arkansas, Florida, Georgia, Maryland, Oklahoma, and Virginia. Users should check their inventory for the listed lot numbers and contact Abbott for further instructions.
The recalled product
- Product
- Alinity i TSH Reagent Kit, List Number 07P4830
- Manufacturer
- Abbott Ireland Diagnostics Division
- Affected units
- 678
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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