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Abbott Ireland Diagnostics Division Recalls
12 recalls on record · December 3, 2014 to August 14, 2019 · Medical Devices
Recalls by year
14
19
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 14, 2019Medical DevicesFDA
Abbott Ireland Diagnostics Division recalls Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle
Hazard: 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.
May 22, 2019Medical DevicesFDA
Abbott Ireland Diagnostics Division recalls Abbott Alinity i Estradiol Reagent Kit - Product Usage: Alinity i Estradiol assay is a chemiluminescent microparticle im
Hazard: Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.
May 22, 2019Medical DevicesFDA
Abbott Ireland Diagnostics Division recalls Abbott ARCHITECT Estradiol Reagent Kit - Product Usage: The ARCHITECT Estradiol assay is a Chemiluminescent Microparticl
Hazard: Patient results may be falsely elevated. This patient impact only applies to patients currently being treated with or recently treated with the drug Mifepristone.
February 13, 2019Medical DevicesFDA
Abbott Ireland Diagnostics Division recalls ARCHITECT Total T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemilumi
Hazard: 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.
February 13, 2019Medical DevicesFDA
Abbott Ireland Diagnostics Division recalls ARCHITECT Free T3 Reagent Kit used on ARCHITECT i1000SR or i2000/i2000SR platforms Product Usage: It is a Chemilumin
Hazard: 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.
January 2, 2019Medical DevicesFDA
Abbott Ireland Diagnostics Division recalls Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
Hazard: 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.
January 2, 2019Medical DevicesFDA
Abbott Ireland Diagnostics Division recalls Alinity i Progesterone Reagent Kit, List Number 08P3620
Hazard: 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.
January 2, 2019Medical DevicesFDA
Abbott Ireland Diagnostics Division recalls Alinity i Estradiol Reagent Kit, List Number 07P5020
Hazard: 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.
January 2, 2019Medical DevicesFDA
Abbott Ireland Diagnostics Division recalls Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
Hazard: 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.
January 2, 2019Medical DevicesFDA
Abbott Ireland Diagnostics Division recalls Alinity i Free T4 Reagent Kit, List Number 07P7030
Hazard: 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.
January 2, 2019Medical DevicesFDA
Abbott Ireland Diagnostics Division recalls Alinity i TSH Reagent Kit, List Number 07P4830
Hazard: 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.
December 3, 2014Medical DevicesFDA
Abbott Ireland Diagnostics Division recalls ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (sheep) coated microp
Hazard: 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.