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U.S. Department of Health and Human Services

Medical Device Recalls

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510(K) Number: K120771
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UniCel DxH 600 Coulter Cellular Analysis System, Catalog No. B23858. 2 05/24/2017 Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B66445, B68304,... 2 05/24/2017 Beckman Coulter Inc.
DxH 600 Coulter Cellular Analysis System, Catalog No. B23858 2 01/11/2017 Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System, Catalog No. 629029, B24465, B24802, B68304 2 01/11/2017 Beckman Coulter Inc.
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 1.1.1.0, Part No. B23858 The DxH ... 2 12/16/2015 Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 629029, B24465, ... 2 12/16/2015 Beckman Coulter Inc.
UniCel DxH 600 Coulter Cellular Analysis System, Software Version 3.0.2.0, Part No. 775222 The UniC... 2 12/16/2015 Beckman Coulter Inc.
COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent... 2 05/15/2015 Beckman Coulter Inc.
UniCel DxH 800 Coulter Cellular Analysis System, Part No. 629029, B24465, and B24802. Used for ... 2 06/20/2014 Beckman Coulter Inc.
UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers... 2 11/04/2013 Beckman Coulter Inc.
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