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U.S. Department of Health and Human Services

Medical Device Recalls
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Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sa... 2 12/21/2023 FEI # 1415939
Abbott Laboratories
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels 3 01/17/2023 FEI # 3016438761
Abbott Laboratories
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27 2 08/30/2022 FEI # 1415939
Abbott Laboratories
REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x... 2 07/22/2022 FEI # 3016438761
Abbott Laboratories
REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 3... 2 07/22/2022 FEI # 3016438761
Abbott Laboratories
REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x... 2 07/22/2022 FEI # 3016438761
Abbott Laboratories
ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are fo... 2 04/07/2022 FEI # 1415939
Abbott Laboratories
ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITEC... 2 11/19/2021 FEI # 3016438761
Abbott Laboratories
ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 R... 2 11/19/2021 FEI # 3016438761
Abbott Laboratories
Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro dia... 2 09/14/2021 FEI # 3016438761
Abbott Laboratories

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