Abbott Ireland Diagnostics Division
Longford Longford, IE
ABBOTT IRELAND DIAGNOSTICS DIVISION appears in FDA device records in Longford Longford, IE. FDA records list 8 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 12 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 8 510(k) clearances for Abbott Ireland Diagnostics Division between 2021 and 2023. The busiest year on record is 2022, with 6. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2021 | 1 |
| 2022 | 6 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K223317 | Alkaline Phosphatase2 | CJE | Substantially Equivalent | |
| K223324 | Total Bilirubin2 | CIG | Substantially Equivalent | |
| K203597 | Cholesterol2 | CHH | Substantially Equivalent | |
| K203771 | Urea Nitrogen2 | CDQ | Substantially Equivalent | |
| K210633 | Amylase2 | JFJ | Substantially Equivalent | |
| K210452 | Creatinine2 | CGX | Substantially Equivalent | |
| K203530 | Albumin BCP2 | CJW | Substantially Equivalent | |
| K203248 | Albumin BCG2 | CIX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005094123 | 3005094123 | ABBOTT IRELAND DIAGNOSTICS DIVISION | Lisnamuck, Longford - IE | 2026 | and 44 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- CGNAcid, Folic, Radioimmunoassay
- KHPAcid, Lactic, Enzymatic Method
- KNKAcid, Uric, Uricase (Colorimetric)
- CDOAcid, Uric, Uricase (U.V.)
- CGXAlkaline Picrate, Colorimetry, Creatinine
- DERAlpha-1-Lipoprotein, Antigen, Antiserum, Control
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- MQMBilirubin (Total And Unbound) In The Neonate Test System
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- CJWBromcresol Purple Dye-Binding, Albumin
- JIXCalibrator, Multi-Analyte Mixture
- JISCalibrator, Primary
- JITCalibrator, Secondary
- JFJCatalytic Methods, Amylase
- JPZColorimetric Method, Gamma-Glutamyl Transpeptidase
- CZWComplement C3, Antigen, Antiserum, Control
- DBIComplement C4, Antigen, Antiserum, Control
- CIGDiazo Colorimetry, Bilirubin
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- DBFFerritin, Antigen, Antiserum, Control
- DADHaptoglobin, Antigen, Antiserum, Control
- CFRHexokinase, Glucose
- CZPIga, Antigen, Antiserum, Control
- DEWIgg, Antigen, Antiserum, Control
- DFTIgm, Antigen, Antiserum, Control
- MMIImmunoassay Method, Troponin Subunit
- CHILipase-Esterase, Enzymatic, Photometric, Lipase
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIYPhotometric Method, Iron (Non-Heme)
- JGJPhotometric Method, Magnesium
- JZJPrealbumin, Antigen, Antiserum, Control
- CDDRadioassay, Vitamin B12
- CHPRadioimmunoassay, Estradiol
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CECRadioimmunoassay, Free Thyroxine
- CEPRadioimmunoassay, Luteinizing Hormone
- JLSRadioimmunoassay, Progesterone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDPRadioimmunoassay, Total Triiodothyronine
- QKOReagent, Coronavirus Serological
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- DHASystem, Test, Human Chorionic Gonadotropin
- DHRSystem, Test, Rheumatoid Factor
- MRGSystem, Test, Vitamin D
- DDGTransferrin, Antigen, Antiserum, Control
- JIQTurbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1354-2019 | Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative The determination of Estradiol in serum and plasma on the Alinity i analyzer. | Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone. | Class II | Terminated | |
| Z-1353-2019 | 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. | Class II | Terminated | |
| Z-2208-2019 | 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 Alinity i analyzer. | 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. | Class II | Terminated | |
| Z-0669-2019 | Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532 | 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. | Class II | Terminated | |
| Z-0668-2019 | Alinity i Progesterone Reagent Kit, List Number 08P3620 | 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. | Class II | Terminated | |
| Z-0667-2019 | Alinity i Estradiol Reagent Kit, List Number 07P5020 | 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. | Class II | Terminated | |
| Z-0666-2019 | Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121 | 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. | Class II | Terminated | |
| Z-0665-2019 | Alinity i Free T4 Reagent Kit, List Number 07P7030 | 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. | Class II | Terminated | |
| Z-0664-2019 | 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. | Class II | Terminated | |
| Z-0799-2019 | ARCHITECT Total 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 (Free T3) in human serum and plasma. | 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. | Class II | Terminated | |
| Z-0798-2019 | 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 (Free T3) in human serum and plasma. | 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. | Class II | Terminated | |
| Z-0474-2015 | 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: ProClin 300. - 1 or 4 Bottle(s) (5.9 mL/26.3 mL) T3 acridinium-labeled conjugate in citrate buffer with NaCl and Triton X-100 stabilizers. Minimum concentration: 0.33 ng/mL. Preservative: ProClin 300. The ARCHITECT Total T3 (TT3) assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total triiodothyronine (Total T33) in human serum and plasma. | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain