BEUDAMED
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    Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612 is a computer-controlled stand-alone system for aliquoting and sorting of barcoded sample tubes. The system operates with an online connection to the host.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·November 2, 2016

    Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use. Modular E170: Immunoassay Analyzer Product Usage: The Roche COBAS INTEGRA 800/800 CTS Analyzer is fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·November 2, 2016

    Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·May 2, 2018

    Calcium Reagent, Calcium Test System for COBAS INTEGRA 400, 400 PLUS, 800, 800 CTS, cobas c 311, 501 and 502, Part number 20763128322, Roche Diagnostics Corporation, Indianapolis, IN. For the in vitro quantitative determination of calcium in serum, plasma and urine.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code CIC·October 11, 2010

    Roche COBAS INTEGRA 800 /800 CTS Analyzer Analyzer, Chemistry (Photometric, Discrete for Clinical use Product Usage: The system cobas p612 is a computer-controlled stand-alone system for aliquoting and sorting of barcoded sample tubes. The system operates with an online connection to the host.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JJE·July 15, 2016

    Roche/Hitachi MODULAR Analytics Combination Systems Modular D/P: Clinical Chemistry Analyzer, Chemistry (Photometric, Discrete) for clinical use. Modular E170: Immunoassay Analyzer Product Usage: The Roche COBAS INTEGRA 800/800 CTS Analyzer is fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JJE·July 15, 2016

    Roche Acetaminophen assay 03255379160-HAcetaminophen (P) 20767174160- cobas c Integra AAcetaminophen150 test

    FDA Recall
    Terminated ·Roche Diagnostics Corporation·Product code LDP·January 2, 2018

    Stryker Ortholock, Stryker, Kalamazoo, MI; Part 6007-003-000. Stryker Ortholock is used to firmly anchor a tracker intended for patient tracking during computer aided orthopaedic and trauma applications.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HAW·June 5, 2008

    Stryker MIS Bur, 3.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-135.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HBE·July 6, 2009

    Stryker MIS Bur, 3.0mm Neuro Diamond Course, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-230.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HBE·July 6, 2009

    Stryker MIS Bur, 2.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-120.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HBE·July 6, 2009

    Stryker MIS Bur, 3.0mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-130.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HBE·July 6, 2009

    Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code ITX·October 20, 2017

    Stryker PainPump ExFen, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-10.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009

    Stryker MIS Bur, 2.5mm Neuro Diamond, sterile, Stryker Instruments, Kalamazoo, MI; REF 8420-107-125.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code HBE·July 6, 2009

    Stryker PainPump base kit, 120 mL infusion kit, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-100.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009

    Stryker PainPump, two site infusion set, sterile, Stryker Instruments, Kalamazoo, MI; REF 500-200.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009

    Stryker PainPump2, 2-site tube set with 5.0" ExFen, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-200-50.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009

    Stryker PainPump2 ExFen 5, 5" extended fenestration catheter set for PainPump2, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-500.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009

    Stryker PainPump2 ExFen 5, 5" catheter set for PainPump2, sterile, Stryker Instruments, Kalamazoo, MI; REF 525-501.

    FDA Recall
    Terminated ·Stryker Instruments Div. of Stryker Corporation·Product code FRN·June 16, 2009