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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 10 of 25 Results
510(K) Number: K023764
 
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Ringed DxI Reaction Vessels (RVs) 2 07/26/2023 Beckman Coulter, Inc.
The Access Cortisol Reagent. REF (Catalog Number) 33600, Lot 831755. A paramagnetic particle, chemi... 2 09/30/2019 Beckman Coulter Inc.
The UniCel DxI 600 and 800 Access Immunoassay Systems, that are connected to an automation line. ... 2 03/30/2019 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.
UniCel DxI 600 Access Immunoassay System Analyzer. The Access Immunoassay System is an in vitro ... 2 02/16/2014 Beckman Coulter Inc.
UniCel Dxl 600 Access Immunoassay System, Part Numbers: A30260, A71460, and A71461. The UniCel Dx... 2 11/19/2012 Beckman Coulter Inc.
UniCel Dxl 800 Access Immunoassay System, Part Numbers: 973100, A71456, and A71457. The UniCel Dx... 2 11/19/2012 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.
UniCel DxI 800 Access Immunoassay Systems, Part Numbers: Dxl 800: 937100; Dxl 800 Remanufactured: ... 2 08/23/2012 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.
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