Abbott Ireland
IrelandFDA applicant, unverified FDA FEI 3008344661
Abbott Ireland is a medical device manufacturer, with 254 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II and I) and 1 FDA recall as of 14 Nov 2026.
- Devices
- 254
- Registrations
- FDA
- FDA recalls
- 11 ongoing
Registry facts
- Registries
- FDA GUDID 252
- EUDAMED 220
- FDA 510(k) 2
- Device classes
- FDA Class II 157
- FDA Class I 97
- FDA recalls
- Identifiers
- FDA FEI 3008344661
- DUNS 989964119
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
What Abbott Ireland makes
The company manufactures in vitro diagnostic (IVD) kits and systems for measuring thyroid hormones—including free thyroxine (FT4), total thyroxine (TT4), total triiodothyronine (TT3), free triiodothyronine (FT3), and thyroid stimulating hormone (TSH)—using chemiluminescent immunoassay technology. It also produces kits for albumin, progesterone, and total aspartate aminotransferase (AST) assays, primarily using spectrophotometry. These products are designed for laboratory use in automated platforms like ARCHITECT and Alinity.
The diagnostic kits fall under FDA device classes I and II, with regulatory submissions including 510(k) clearances and Unique Device Identifier (UDI) listings. The company’s products are authorised for use in the United States, where the manufacturer is based.
Catalogue
Search and filter all 254 devicesShowing 1-50 of 254
Company details
- FDA FEI number
- 3008344661
- DUNS number
- 989964119
- Address
- DIAGNOSTICS DIVISION, SLIGO
- xx@xx.xx
- Phone
- +1(877)422-2688
FDA recalls
FDA recall records list 1 recall initiated by ABBOTT IRELAND, initiated on 2023-04-24. By recorded status: 1 ongoing. The reasons filed fall into these groups: labeling or instructions for use and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 1
- 2024 0
- 2025 0
- 2026 0
2023
- 24 Apr 2023 Z-1696-2023 Class III Ongoing Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).
Full distribution text
- 24 Apr 2023 Z-1696-2023 Class III Ongoing Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU).
Frequently asked questions
How many devices does ABBOTT IRELAND have in the registry?
The registry currently lists 254 devices for ABBOTT IRELAND. Devices recorded under merged duplicate company entries are counted once.
Which registries list ABBOTT IRELAND's devices?
Among its 50 most recently registered devices, ABBOTT IRELAND has devices listed in EUDAMED (40 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do ABBOTT IRELAND's devices fall under?
Among its 50 most recently registered devices, the classes recorded for ABBOTT IRELAND's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for ABBOTT IRELAND?
FDA recall records list 1 recall initiated by ABBOTT IRELAND, the most recent initiated on 24 Apr 2023. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from ABBOTT IRELAND in the registry?
The most recently registered devices listed for ABBOTT IRELAND include ARCHITECT 04T0130, Alinity 04T9730, Alinity 04T9720 and ARCHITECT 04T0120.