Abbott Ireland Diagnostics Division
FDA adverse event reports naming Abbott Ireland Diagnostics Division as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: ABBOTT IRELAND DIAGNOSTICS DIVISION.
- Total reports
- 2,646
- Deaths
- 0
- Injuries
- 51
- Malfunctions
- 2,595
Reports per year
Source: FDA adverse event reports by year received, 2019–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Immunoassay Method, Troponin SubunitMMI722
- Radioimmunoassay, Free ThyroxineCEC504
- Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)LOM395
- System, Test, Human Chorionic GonadotropinDHA378
- Radioimmunoassay, Thyroid-Stimulating HormoneJLW156
- Enzyme Linked Immunoabsorbent Assay, CytomegalovirusLFZ69
- Radioimmunoassay, Prolactin (Lactogen)CFT63
- Photometric Method, MagnesiumJGJ53
- Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate CancerMTF53
- Serology Tests Used For Infectious Disease Screening Of Blood And Plasma DonationsQHM42
Recent recalls
- 2014-12-03TerminatedEmployee error
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.
- TerminatedNonconforming Material/Component
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.
- TerminatedNonconforming Material/Component
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.
- TerminatedNonconforming Material/Component
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.
- TerminatedNonconforming Material/Component
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.
- TerminatedNonconforming Material/Component
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.
- TerminatedNonconforming Material/Component
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.
- TerminatedDevice Design
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.
- TerminatedDevice Design
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.
- TerminatedUnder Investigation by firm
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.
Monitor Abbott Ireland Diagnostics Division automatically
DeviceWatch watches FDA adverse events and recalls for the products you care about, summarizes clinical narratives with AI and alerts you when a safety signal emerges.