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    Dengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054

    FDA Recall
    Terminated ·LumiQuick Diagnostics Inc.·March 4, 2014

    Cell Marque, Podoplanin (D2-40 Mab), 7 mL, REF PA0796, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Podoplanin (D2-40) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods

    FDA Recall
    Terminated ·Leica Biosystems Richmond Inc.·Product code NJT·July 14, 2017

    Cell Marque, Glypican-3 (1G12 Mab), 7 mL, REF PA0800, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Glypican-3 (1G12) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Glypican-3 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing.

    FDA Recall
    Terminated ·Leica Biosystems Richmond Inc.·Product code NJT·July 14, 2017

    Cell Marque, Napsin A (MRQ-60 Mab.), 7 mL, REF PA0805, IVD, The antibody is intended for in vitro diagnostic (IVD) use. Napsin A (MRQ-60) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the Napsin A protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing.

    FDA Recall
    Terminated ·Leica Biosystems Richmond Inc.·Product code NJT·July 14, 2017

    Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing

    FDA Recall
    Terminated ·Leica Biosystems Richmond Inc.·Product code NJT·July 14, 2017

    Cell Marque, MSH6 (44 Mab.), 7 mL, REF PA0804, IVD, The antibody is intended for in vitro diagnostic (IVD) use. MSH6 is a mismatch repair gene which is deficient in a high proportion of patients with microsatellite instability (MSI-H). This finding is associated with the autosomal dominant condition known as Hereditary Non-Polyposis Colon Cancer (HNPCC).

    FDA Recall
    Terminated ·Leica Biosystems Richmond Inc.·Product code NJT·July 14, 2017

    Cell Marque, Microphthalmia Transcription Factor (MiTF) (C5/D5 Mab.), 7 mL, REF PA0803, IVD, The antibody is intended for in vitro diagnostic (IVD) use. The Microphthalmia Transcription Factor (MiTF) (C5/D5) antibody is intended for qualified laboratories to qualitatively identify by light microscopy the presence of associated antigens in sections of formalin-fixed, paraffin-embedded tissue sections using IHC test methods.

    FDA Recall
    Terminated ·Leica Biosystems Richmond Inc.·Product code NJT·July 14, 2017

    Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted and ready to use. They are the same product with the same intended use. Chemistry - IVD Smooth Muscle Actin (SMA) antibody recognizes the alpha-smooth muscle isoform of actin. This antibody recognizes the alpha-smooth muscle isoform of actin. This MAb is reportedly useful for identifying tumors arising from smooth muscle and myoepithelial cells.

    FDA Recall
    Terminated ·Biocare Medical, LLC·Product code NJT·September 8, 2015

    MICRO-X ROVER MOBILE X-RAY SYSTEM, MXU-RV19

    FDA Recall
    Open, Classified ·Micro-X Ltd. A14 6 MAB Eastern Promenade Tonsley Australia·Product code IZL·August 31, 2022

    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number:MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

    FDA Recall
    Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·April 4, 2025

    MICRO-X Rover Mobile X-ray System, # MXU-RV35; MICRO-X Rover Mobile X-ray System, # MXU-RV71

    FDA Recall
    Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·November 28, 2023

    MICRO-X Rover Mobile X-ray System, # MXU-RV35

    FDA Recall
    Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·May 31, 2023

    Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71

    FDA Recall
    Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·March 27, 2026

    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71, MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

    FDA Recall
    Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·April 4, 2025

    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV35 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

    FDA Recall
    Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·March 28, 2025

    MICRO-X Rover Mobile X-ray System, # MXU-RV35

    FDA Recall
    Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·October 22, 2024

    Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog Number: MXU-RV71 Product Description: Rover Mobile X-rays System ("Rover") is a mobile imaging system that incorporates a self-contained X-ray generator, imaging display and software for acquiring medical diagnostic images outside a standard X-ray room. It is designed specifically for Digital Radiography (DR) with vendor-supported detectors. The Rover is designed to perform radiographic X-ray examinations for disease/injury detection, diagnosis, medical and surgical treatment planning, and therapy monitoring, where patient condition contraindicates transport to a fixed X-ray unit The Rover can be used on pediatric and adult patients, in all patient treatment areas Component: N/A

    FDA Recall
    Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·March 28, 2025

    MICRO-X Rover Mobile X-ray System, # MXU-RV19

    FDA Recall
    Open, Classified ·Micro-X Ltd. Unit 14 6 Mab Eastern Promenade Tonsley Australia·Product code IZL·October 23, 2024

    Energy FX: a) original Aluminum (100-3A) b) sleek (adult and kid & pet) (100-3B)

    FDA Recall
    Completed ·Basic Reset Inc.·Product code N/A·October 18, 2019

    (1) Arrow STIM CPNB TUOHY NDL: 18G x 14CM (5-1/2") AB-18140-N (2) Arrow STIM CPNB TUOHY NDL: 18G x 11CM (4-3/8") AB-18110-N (3) Arrow STIM CPNB TUOHY NDL: 18G x 8CM (3-1/8") AB-18080-N (4) Arrow STIM CPNB TUOHY NDL: 17G x 8CM (3-1/8") AB-17080-N (5) Arrow STIM CPNB TUOHY NDL: 17G x 14CM (5-1/2") AB-17140-N (6) Arrow INSL CPNB TUOHY NDL: 17G x 15CM (6") AB-00150 (7) Arrow STIM CPNB TUOHY NDL: 17G x 11CM (4-3/8") AB-17110-N

    FDA Recall
    Terminated ·Arrow International Inc·Product code CAZ·December 20, 2019