Manufacturer

Abbott Ireland Diagnostics Division

12 recalls in our database name Abbott Ireland Diagnostics Division as the manufacturing or recalling firm.

What the numbers show

Total: 12
Critical: 0
Severe: 0
Most recent: 2019-08-14

Of the 12 recalls from Abbott Ireland Diagnostics Division we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–12 of 12

ModerateFDA (Devices)·Z-2208-2019·2019-08-14
Abbott Recalls Alinity i Ferritin Reagent Kits Due to Manufacturing Defect
Abbott Ireland Diagnostics Division is recalling 216 units of Alinity i Ferritin Reagent Kits due to a manufacturing issue that may cause bottle neck damage and instrument failure.
Product
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.
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-1354-2019·2019-05-22
Abbott Alinity i Estradiol Reagent Kit Recalled for False Results
Abbott Ireland Diagnostics Division is recalling Alinity i Estradiol Reagent Kits because patient results may be falsely elevated for individuals treated with Mifepristone.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1353-2019·2019-05-22
Abbott ARCHITECT Estradiol Reagent Kit Recall for Mifepristone Interference
Abbott is recalling ARCHITECT Estradiol Reagent Kits because patient results may be falsely elevated for individuals currently or recently treated with Mifepristone.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0798-2019·2019-02-13
Abbott Recalls Free T3 Reagent Kits Due to Carryover Issues
Abbott Ireland Diagnostics Division is recalling ARCHITECT Free T3 Reagent Kits because reagent carryover may cause depressed test results on specific platforms.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0799-2019·2019-02-13
Abbott Recalls ARCHITECT Total T3 Reagent Kits Due to Carryover
Abbott Ireland Diagnostics Division is recalling ARCHITECT Total T3 Reagent Kits because reagent carryover may cause depressed test results on specific platforms.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0665-2019·2019-01-02
Abbott Alinity i Free T4 Reagent Kit Recalled for Manufacturing Defect
Abbott is recalling 294 units of Alinity i Free T4 Reagent Kits due to a manufacturing issue that may cause bottle neck damage and instrument loading failures.
Product
Alinity i Free T4 Reagent Kit, List Number 07P7030
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0667-2019·2019-01-02
Abbott Alinity i Estradiol Reagent Kit Recalled for Manufacturing Defect
Abbott is recalling 79 units of Alinity i Estradiol Reagent Kits due to a manufacturing issue that may cause bottle neck damage and instrument failure.
Product
Alinity i Estradiol Reagent Kit, List Number 07P5020
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0664-2019·2019-01-02
Abbott Alinity i TSH Reagent Kit Recalled for Manufacturing Defect
Abbott is recalling Alinity i TSH Reagent Kits due to a manufacturing issue that may damage bottle necks, potentially causing reagent loading failures on the instrument.
Product
Alinity i TSH Reagent Kit, List Number 07P4830
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0669-2019·2019-01-02
Abbott Alinity i 25-OH Vitamin D Reagent Kit Recall for Manufacturing Defect
Abbott is recalling specific lots of Alinity i 25-OH Vitamin D Reagent Kits due to a manufacturing issue that may damage bottle necks and cause instrument failure.
Product
Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0668-2019·2019-01-02
Abbott Alinity i Progesterone Reagent Kit Recalled for Manufacturing Defect
Abbott is recalling 157 units of Alinity i Progesterone Reagent Kits due to a manufacturing issue that can cause bottle neck damage and instrument failure.
Product
Alinity i Progesterone Reagent Kit, List Number 08P3620
Category
Medical Device
Distribution
6 states
ModerateFDA (Devices)·Z-0666-2019·2019-01-02
Abbott Recalls Alinity i Total Beta-hCG Reagent Kit Due to Manufacturing Defect
Abbott is recalling 27 units of the Alinity i Total Beta-hCG Reagent Kit because a manufacturing issue may damage bottle necks, causing reagent loading failures on the instrument.
Product
Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
Category
Medical Device
Distribution
6 states
HighFDA (Devices)·Z-0474-2015·2014-12-03
Abbott Recalls ARCHITECT Total T3 Reagent Kits Due to Potential Result Errors
Abbott Ireland Diagnostics Division is recalling 7,415 ARCHITECT Total T3 Reagent Kits because 17% of specific lots may produce patient results higher than expected.
Product
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 ac
Category
Medical Device
Distribution
Distributed nationwide