Data / Medical devices / Ireland / Abbott Ireland Diagnostics Division
Abbott Ireland Diagnostics Division: FDA-registered device maker in Longford, Ireland, 40 510(k) clearances
Abbott Ireland Diagnostics Division is registered with the FDA (registration 3005094123) in Longford, Ireland. It lists 54 device types. The FDA files 40 510(k) clearances under its listings, the newest dated October 24, 2025. 5 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3005094123
- Address
- Lisnamuck, Longford, Ireland, -
- Owner or operator
- ABBOTT LABORATORIES (1415939)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- February 14, 1996
- Registered through
- 2027
- Brand names listed
- ACE Calibrator (LN 06U8201), ACE Calibrator (LN 06U8601), ACE Control (LN 06U8210), ACE Control (LN 06U8610), ACTIVATED ALANINE AMINOTRANSFERASE (A-ALT) (LN 8L92-21, 8L92-41, 8L92-22, 8L92-42), ALANINE AMINOTRANSFERASE (ALT) (LN 7D56-21, 7D56-22), APOLIPOPROTEIN A1 (ApoA) (LN 9D92-21, 9D92-22), APOLIPOPROTEIN B (APOB) (LN 9D93-21, 9D93-22) and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 24, 2025 | K252357 | Glucose2 | CFR | Substantially Equivalent | Abbott Ireland | accessdata.fda.gov |
| July 21, 2023 | K223317 | Alkaline Phosphatase2 | CJE | Substantially Equivalent | Abbott Ireland Diagnostics Division | accessdata.fda.gov |
| May 4, 2023 | K230994 | Alinity i STAT High Sensitivity Troponin-I | MMI | Substantially Equivalent | Abbott Laboratories Diagnostics Division | accessdata.fda.gov |
| December 29, 2022 | K223324 | Total Bilirubin2 | CIG | Substantially Equivalent | Abbott Ireland Diagnostics Division | accessdata.fda.gov |
| June 30, 2022 | K203597 | Cholesterol2 | CHH | Substantially Equivalent | Abbott Ireland Diagnostics Division | accessdata.fda.gov |
| May 26, 2022 | K210633 | Amylase2 | JFJ | Substantially Equivalent | Abbott Ireland Diagnostics Division | accessdata.fda.gov |
| May 19, 2022 | K202525 | Alinity i STAT High Sensitivity Troponin-I | MMI | Substantially Equivalent | Abbott Laboratories Diagnostics Division | accessdata.fda.gov |
| March 22, 2022 | K210452 | Creatinine2 | CGX | Substantially Equivalent | Abbott Ireland Diagnostics Division | accessdata.fda.gov |
| March 18, 2022 | K203530 | Albumin BCP2 | CJW | Substantially Equivalent | Abbott Ireland Diagnostics Division | accessdata.fda.gov |
| November 23, 2021 | K203248 | Albumin BCG2 | CIX | Substantially Equivalent | Abbott Ireland Diagnostics Division | accessdata.fda.gov |
| September 13, 2019 | K191595 | ARCHITECT STAT High Sensitivity Troponin-I | MMI | Substantially Equivalent | Abbott Laboratories Diagnostics Division | accessdata.fda.gov |
| September 12, 2018 | K181748 | Magnesium | JGJ | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| October 27, 2017 | K173122 | Abbott Architect Free T4 | CEC | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| October 23, 2017 | K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i System | DHA | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| October 19, 2017 | K170316 | ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM | CFR | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| February 15, 2017 | K170160 | Abbott ARCHITECT Free T3 | JIT | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| August 12, 2016 | K153375 | ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls | MRG | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| July 10, 2015 | K151566 | Abbott ARCHITECT Total T4 Calibrators | JIT | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 27, 2012 | K123379 | ABBOTT ARCHITECT FREE T4 | CEC | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| May 17, 2012 | K121314 | ARCHITECT B12 | CDD | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| June 10, 2011 | K111023 | ABBOTT ARCHITECT LH CALIBRATORS | JIT | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| March 5, 2010 | K092740 | ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 | CGN | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| August 18, 2004 | K041687 | ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR | JJX | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| October 6, 2003 | K032458 | ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT | JIT | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| April 11, 2003 | K030320 | WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET | JIS | Substantially Equivalent | Wako Chemicals USA, Inc. | accessdata.fda.gov |
| January 15, 2003 | K024067 | RHEUMATOID FACTOR (RF) | DHR | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| January 29, 1999 | K983289 | APOLIPOPROTEIN A1 | DER | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| January 26, 1999 | K983281 | APOB | DFC | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| December 7, 1998 | K983759 | ABBOTT ARCHITECT FERRITIN | DBF | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| December 1, 1998 | K983424 | ABBOTT ARCHEITECT TOTAL B-HCG | DHA | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 25, 1998 | K983440 | ABBOTT ARCHITECT TOTAL T4 | KLI | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 20, 1998 | K983442 | ABBOTT ARCHITECT TSH | JLW | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 20, 1998 | K983439 | ABBOTT ARCHITECT FREE T3 | CDP | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 20, 1998 | K983434 | ABBOTT ARCHITECT TOTAL T3 | CDP | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 4, 1998 | K983441 | C3 | CZW | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 4, 1998 | K983359 | IGA | CZP | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 4, 1998 | K983356 | C4 | DBI | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 4, 1998 | K983221 | IGG | DEW | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 4, 1998 | K983167 | TRF | DDG | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
| November 4, 1998 | K983132 | IGM | DFT | Substantially Equivalent | Abbott Laboratories | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 5, 2019 | 82129 | Class II | Terminated | Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of Estradiol in human serum and plasma. | Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone. | accessdata.fda.gov |
| November 21, 2018 | 83341 | Class II | Terminated | Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the | Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument. | accessdata.fda.gov |
| November 21, 2018 | 81632 | Class II | Terminated | Alinity i TSH Reagent Kit, List Number 07P4830 | Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument. | accessdata.fda.gov |
| October 12, 2018 | 81402 | Class II | Terminated | ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free triiodothyronine (Fre | Samples tested using ARCHITECT Free T3 or ARCHITECT Total T3 assays may show depressed results due to a reagent carryover when testing on board with specific assays on the ARCHITECT i1000SR and i2000/i2999SR platforms. | accessdata.fda.gov |
| September 11, 2014 | 69289 | Class II | Terminated | ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microparticles in MES buffer with sheep IgG stabilizers. Minimum Concentration: 0.08% solids. Preservative: Pr | 17% of ARCHITECT Total T3 Reagent Kit, LN 7K64-20/-25 reagent lots 38901UI00 and 38901UI01 may exhibit lower Relative Light Units (RLUs) than expected, which in turn may result in controls out of range or patient results higher than expected. | accessdata.fda.gov |
Compare with other makers
- All makers of Calibrator, Secondary
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of System, Test, Vitamin D
- All makers of Igg, Antigen, Antiserum, Control
- All makers of Lipase-Esterase, Enzymatic, Photometric, Lipase
- All makers of Radioimmunoassay, Estradiol
Updated October 24, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.