BEUDAMED
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    VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 111 2820

    FDA Recall
    Open, Classified ·QUIDELORTHO·Product code JIS·April 9, 2024

    VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 131 5589

    FDA Recall
    Open, Classified ·QUIDELORTHO·Product code CDP·April 9, 2024

    Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code PAM·November 7, 2023

    SoftMic Versions 4.0.4.7, 4.5.1.3. Version 4.0.4.7 Manufactured 02/03/2010. Version 4.5.1.3 Manufactured 03/18/2010. SCC Soft Computer 5400 Tech Data Drive Clearwater, FL 33760.

    FDA Recall
    Terminated ·SCC Soft Computer·Product code LNX·July 19, 2010

    QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.

    FDA Recall
    Terminated ·Qiagen Sciences LLC·Product code OOI·January 28, 2020

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 6), Product Code 35700BAX

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·November 19, 2024

    Baxter SIGMA Spectrum Infusion Pump with Master Drug Library (Version 8), Product Code 35700BAX2

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FRN·November 19, 2024

    VITROS Chemistry Products ECO2 Slides-For in vitro diagnostic use only. VITROS Chemistry Products ECO2 Slides quantitatively measure total carbon dioxide (CO2) concentration in serum and plasma using VITROS 250/350/5,1 FS/4600 XT 3400 Chemistry Systems and the VITROS 5600/ XT 7600 Integrated System. Bicarbonate/carbon dioxide measurements are used in the diagnosis and treatment of numerous potentially serious disorders associated with changes in body acid-base balance. Product Code: 8262396

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, INc.·Product code KHS·October 25, 2023

    BD Nano 2nd Gen Pen Needles 32G X 4mm (5-count sample contained in Patient Counseling Sample Toolbox -Catalog 6484755/Lot Number: 3750144)-Sterile, single use devices designed for the parenteral administration of a drug from a cartridge contained in a drug pen injector Model/Catalog Number: 320551

    FDA Recall
    Open, Classified ·Embecta Corp.·Product code FMI·June 18, 2024

    VITROS Chemistry Products CRP Slides- In vitro diagnostic quantitatively measures C-reactive protein (CRP) concentration in serum and plasma Model/Catalog Number: 1926740

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code DCK·October 11, 2024

    NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E

    FDA Recall
    Open, Classified ·Product code BYS·October 11, 2023

    NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E

    FDA Recall
    Open, Classified ·Product code BYS·October 11, 2023

    Incisive CT Power (China)-Computed Tomography X-Ray System Model: 728148

    FDA Recall
    Open, Classified ·Philips North America·Product code JAK·April 25, 2023

    Incisive CT-Computed Tomography X-Ray System Model: 728143

    FDA Recall
    Open, Classified ·Philips North America·Product code JAK·April 25, 2023

    Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·April 15, 2024

    Incisive CT Plus-Computed Tomography X-Ray System Model: 728149

    FDA Recall
    Open, Classified ·Philips North America·Product code JAK·April 25, 2023

    Incisive CT for Brazil SKD-Computed Tomography X-Ray System Model: 728146

    FDA Recall
    Open, Classified ·Philips North America·Product code JAK·April 25, 2023

    Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code JAK·April 15, 2024

    Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic surgical procedures Product Number: 72205104

    FDA Recall
    Open, Classified ·Smith & Nephew, Inc.·Product code KQZ·December 14, 2021

    VITROS Immunodiagnostic Products Vitamin B12 Range Verifier - In vitro diagnostic use ly. 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 vitamin B12 - Product Code: 6800872

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code JJX·May 8, 2024