BEUDAMED
    115 results · 39ms · Sources: EU EUDAMED, US FDA

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    Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066001

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·May 13, 2021

    Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical specimens SMN 11067000

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JGS·May 13, 2021

    Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical specimens SMN 11066000

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code JLW·May 13, 2021

    Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model number LN 03R70-01

    FDA Recall
    Open, Classified ·Abbott Laboratories·Product code JJE·July 26, 2021

    Liquid Assayed Specific Protein Control Level 3- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2684

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JJY·November 22, 2022

    Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JJY·November 22, 2022

    Liquid Assayed Specific Protein Control Level 2- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2683

    FDA Recall
    Open, Classified ·Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland·Product code JJY·November 22, 2022

    Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative measurement of tacrolimus in human whole blood on the Dimension clinical chemistry system SMN: 10700795 (DF207)

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code MLM·January 30, 2023

    DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065. The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code JJE·March 20, 2025

    DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code JJE·February 26, 2025

    VITROS Immunodiagnostic Products NT-proBNP II Range Verifiers-For in vitro diagnostic use only. For use in verifying the calibration range of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Integrated Systems when used for the quantitative measurement of N-terminal pro Brain Natriuretic Peptide (NT-proBNP). Catalog Number: 6192257, Lot number: 0090

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJX·May 18, 2023

    DxC 500 AU Clinical Chemistry Analyzer, Catalog Numbers/UDI codes: C63519 / 14987666545058 C63520 / 14987666545065 Software versions: V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3 The Beckman Coulter DxC 500 AU Clinical Chemistry Analyzer is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

    FDA Recall
    Open, Classified ·Beckman Coulter Inc.·Product code JJE·March 17, 2025

    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

    FDA Recall
    Open, Classified ·Beckman Coulter Mishima K.K. 454-32 Higashino; Nagaizumi-Cho Sunto-Gun Japan·Product code JJE·July 10, 2024

    DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemistry analyzer that measures analytes in samples, in combination with appropriate reagents, calibrators, quality control (QC) material and other accessories. This system is for in vitro diagnostic use only.

    FDA Recall
    Open, Classified ·Beckman Coulter Mishima K.K. 454-32 Higashino; Nagaizumi-Cho Sunto-Gun Japan·Product code JJE·June 5, 2024

    IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Number (SMN): 10708840 For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of allergen-specific IgE in human serum, as an aid in the clinical diagnosis of IgE mediated allergic disorders.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DHB·November 4, 2022

    VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly

    FDA Recall
    Open, Classified ·LivaNova USA Inc·Product code LYJ·November 16, 2018

    ACUSON NX2 Elite Diagnostic Ultrasound System, Model # 11284500, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869050775 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc.·Product code IYN·January 28, 2019

    ACUSON NX2 Diagnostic Ultrasound System, Model # 11284381, RX Only, Siemens Medical Solutions, containing software version VA10A, VA10B, VA11A, VA11B; UDI # 04056869030005 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc.·Product code IYN·January 28, 2019

    The OEC 9900 C-Arm is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The GE OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures, and is also intended for cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures.

    FDA Recall
    Open, Classified ·Ge Healthcare·Product code RCC·May 8, 2020

    ACUSON NX3 Elite Diagnostic Ultrasound System, Model # 11235411, RX Only, Siemens Medical Solutions, containing software versions: VA10A, VA10B, VA10C, VA10D, VA10E, VA10F, VB20A, and VB20B; UDI # 04056869004303 The ACUSON NX2 diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications. The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc.·Product code IYN·January 28, 2019