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U.S. Department of Health and Human Services

Medical Device Recalls

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510(K) Number: K083173
 
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Product Description
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VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 68029... 2 07/01/2020 Ortho Clinical Diagnostics
VITROS 5600 Integrated System Software Versions 3.3.3 and below Product Code: 6802413 Unique Id... 2 07/01/2020 Ortho Clinical Diagnostics
VITROS 3600 Immunodiagnostic System - Refurbished Product Code: 6802914 Unique Identifier: 107587... 2 07/01/2020 Ortho Clinical Diagnostics
VITROS 3600 Immunodiagnostic System Software Versions 3.3.3 and below Product Code: 6802783, Unique... 2 07/01/2020 Ortho Clinical Diagnostics
VITROS XT 7600 Integrated System Software Versions 3.5.1 and below Product Code:6844461 Uniq... 2 07/01/2020 Ortho Clinical Diagnostics
VITROS® 3600 Immunoassay System-Software V3.3.2 & below Product Code: 6802783 For use in the in... 2 05/06/2019 Ortho-Clinical Diagnostics
VITROS® 3600 Immunoassay System Refurbished-Software V3.3.2 & below Product Code: 6802914 For u... 2 05/06/2019 Ortho-Clinical Diagnostics
VITROS® 3600 Immunodiagnostic System, Version 3.3.1 & below For use in the in vitro quantitative... 2 12/20/2018 Ortho-Clinical Diagnostics
VITROS Immunodiagnostic Products TSH Reagent Pack 3 04/10/2018 Clinical Diagnostic Systems
VITROS Immunodiagnostic Products TSH Reagent Pack, REF/Catalog Number/Product Code 191 2997, Unique ... 3 08/17/2016 ORTHO-CLINICAL DIAGNOSTICS
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