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    UniCel DxC 880i, 860i, 680i, and 660i Integrated Systems, Part Numbers: A64871, A64903, A64935, A59102. The UniCel DxI Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The UniCel DxC series of instruments is a DxI Immunoassay System integrated with a chemistry analyzer.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code CEM·August 1, 2011

    ABL90 FLEX Analyzer, Model Numbers 393-090, with software versions below 3.4MR2 - Product Usage: It is intended for use in a laboratory environment, near patient or point-of-care setting.

    FDA Recall
    Terminated ·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code CEM·February 3, 2020

    Inpeco FlexLab, ARCHITECT cSystem c8000/c16000 Interface Module, Part Numbers: FLX-208-00, FLX-208-10 - Product Usage: The FlexLab (aka Accelerator a3600) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

    FDA Recall
    Terminated ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·April 7, 2020

    Accelerator a3600 system with Sysmex XN-9000/XN-9100 Interface Module (dual robot) FLX-290-10; FLX-290-20 and Track to Rack Module FLX-295-10- Intended Clinical Chemistry Test Systems - Product Usage: The FlexLab 3.6 Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The system consolidates analytical instruments, such as the ARCHITECT c8000 System into a unified workstation that perform a variety of instrument specific assays such as Sodium, Potassium and Chloride. Sodium, Potassium and Chloride measurements are used in the diagnosis and treatment of diseases involving electrolyte imbalance.

    FDA Recall
    Terminated ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·August 7, 2020

    Cobas b 221<4>Roche OMNI S4 system; Catalog numbers: 3337138001 and 3337138692 The Roche Diagnostics Omni S Analyzer is a fully automated critical care analyzer intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, chloride, hematocrit, glucose, lactate, urea/BUN, total hemoglobin, oxygen saturation, oxyhemoglobin, deoxyhemoglobin, carboxyhemoglobin, and methemoglobin in samples of whole blood, serum, plasma, and aqueous solutions as appropriate.

    FDA Recall
    Terminated ·Roche Diagnostics Corporation·Product code CEM·February 22, 2018

    FlexLab (FLX) Automation System with the Aliquoter Module (Inpeco P/N FLX-212) The FlexLab (aka Accelerator a3600 and Aptio Automation) is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. The systems consolidate multiple Analytical instruments into a unified workstation.

    FDA Recall
    Terminated ·Inpeco S.A. Via San Gottardo 10 Lugano Switzerland·Product code CEM·July 14, 2020

    Medica Capillary Tubes; EasyBloodGas/EasyStat Capillary Tube Kit.

    FDA Recall
    Open, Classified ·Medica Corporation·Product code CEM·December 31, 2025

    System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

    FDA classification
    FDA Class 2 ·System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations

    Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator

    FDA Recall
    Terminated ·Sorin CRM SAS Cvk 4, avenue Reaumur Clamart Cedex France·Product code NIK·July 9, 2018

    TECOTHERM NEO, 100-130/200-240 VAC, 50-60 Hz/ max. 350VA, Class I, Schutzklasse I IP 20, UDI: 04260498580002 - Product Usage: The Thermo-Regulation System TECOTHERM NEO is designed for controlled cold & heat treatment procedures. By means of a mattress, cold and heat is provided to the patient, depending on the therapy objective.

    FDA Recall
    Terminated ·Tec Com Gmbh Eingang B Am Krummling 1 Kabelsketal Germany·Product code DWJ·August 14, 2018

    Sorin Platinium CRT-D 1741 DF-4, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator

    FDA Recall
    Terminated ·Sorin CRM SAS Cvk 4, avenue Reaumur Clamart Cedex France·Product code NIK·July 9, 2018