Abbott Ireland

Medical device manufacturer in Longford, IE.

2510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K252357Glucose2CFR · Traditional 10/24/2025SE
K244042Calcium2CJY · Traditional 02/10/2025SE

Recalls

RecallProductInitiated
Z-1696-2023 Class IIIAlinity i Anti-TPO Reagent Kit, List Number 09P3521Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume… 04/24/2023Open, Classified