Abbott Ireland Diagnostics Division: Medical Device Recalls in 2019

According to to data from the FDA, there were 11 medical device recalls made by Abbott Ireland Diagnostics Division in 2019. See the details of the recalls below.

You can see similar recalls for other firms.

• Alinity i Progesterone Reagent Kit, List Number 08P3620
• Alinity i 25-OH Vitamin D Reagent Kit, List Number 08P4532
• 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.
• Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121
• Alinity i TSH Reagent Kit, List Number 07P4830
• Alinity i Estradiol Reagent Kit, List Number 07P5020
• Alinity i Free T4 Reagent Kit, List Number 07P7030
• 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.
• 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.
• 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.
• 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.