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U.S. Department of Health and Human Services

Medical Device Recalls

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Alinity i Progesterone Reagent Kit, List Number 08P3620 2 12/22/2018 FEI # 3005094123
Abbott Ireland Diagnostics Division
Alinity i Total Beta-hCG Reagent Kit, List Number 07P5121 2 12/22/2018 FEI # 3005094123
Abbott Ireland Diagnostics Division
Alinity i Free T4 Reagent Kit, List Number 07P7030 2 12/22/2018 FEI # 3005094123
Abbott Ireland Diagnostics Division
Alinity i TSH Reagent Kit, List Number 07P4830 2 12/22/2018 FEI # 3005094123
Abbott Ireland Diagnostics Division
Alinity i Estradiol Reagent Kit, List Number 07P5020 2 12/22/2018 FEI # 3005094123
Abbott Ireland Diagnostics Division
ARCHITECT Total T3 Reagent Kit (7K64) consists of: - 1 or 4 Bottle(s) (6.6 mL/27.0 mL) anti-T3 (... 2 12/03/2014 FEI # 3005094123
Abbott Ireland Diagnostics Division
Alinity i Anti-TPO Reagent Kit, List Number 09P3521 3 06/08/2023 FEI # 3008344661
Abbott Ireland Limited
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20 2 12/18/2025 FEI # 3016438761
Abbott Laboratories
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 ... 2 11/12/2025 FEI # 2919069
Abbott Laboratories
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-10 Software Ver... 2 04/22/2025 FEI # 1415939
Abbott Laboratories

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