Abbott Ireland Diagnostics Division
Abbott Ireland Diagnostics Division holds FDA 510(k) medical device clearances, first cleared 2021, most recent 2023, with 12 FDA device recalls on record.
Top product codes for Abbott Ireland Diagnostics Division
FDA recalls by Abbott Ireland Diagnostics Division
10 most recent of 12- 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.
- 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.
- Z-0668-2019 — Alinity i Progesterone Reagent Kit, List Number 08P3620
- Z-0669-2019 — Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
- Z-0666-2019 — Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
- Z-0664-2019 — Alinity i TSH Reagent Kit, List Number 07P4830
- Z-0667-2019 — Alinity i Estradiol Reagent Kit, List Number 07P5020
- Z-0665-2019 — Alinity i Free T4 Reagent Kit, List Number 07P7030
- 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.
- 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.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Abbott Ireland Diagnostics Division
Data sourced from openFDA. This site is unofficial and independent of the FDA.