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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 35 Results
510(K) Number: K042291
 
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ISE Electrolyte Reference (2 X 2L) Reagent, REF A28937, UDI: 15099590202491 - Product Usage: are int... 2 05/28/2020 Beckman Coulter Inc.
UniCel DxC 660i, 680i, 860i, and 880i SYNCHRON Access Clinical Systems, that are re-configured so th... 2 03/30/2019 Beckman Coulter Inc.
UniCel DxC Synchron Clinical Systems and UniCel DxC Synchron Access Integrated Clinical Systems T... 2 07/22/2016 Beckman Coulter Inc.
UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative,... 2 09/23/2014 Beckman Coulter Inc.
Ultrasonic Transducer Kits For use with the Access Family of Immunoassay Systems*. *The Access F... 2 06/09/2014 Beckman Coulter Inc.
UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A591... 2 11/19/2012 Beckman Coulter Inc.
UniCel® DxC 600/800 with Software v5.0.11, Part Number B12218. The UniCel® DxC Synchron® Clinica... 2 10/24/2012 Beckman Coulter Inc.
Unicel Closed Tube Aliquotter (UCTA) for UniCel DxC 660i, UniCel DxC 680i, UniCel DxC 860i, UniCel D... 2 10/12/2012 Beckman Coulter Inc.
UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems, Part Numbers: DxC 660i: A648... 2 08/23/2012 Beckman Coulter Inc.
UniCel DxI 600 Access Immunoassay Systems, Part Numbers: Dxl 600: A30260; Dxl 600 with spot B: A... 2 08/23/2012 Beckman Coulter Inc.
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