BEUDAMED
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    Olympus Ultrasound Endoscope, Model number: GF-UCT180 - Product Usage: used with an Olympus universal endoscopic ultrasound center or a diagnostic system (ALOKA CO. LTD), video system center, light source, documentation equipment, monitor, EndoTherapy accessories and other ancillary equipment.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code IYN·October 16, 2020

    Olympus Ultrasound Endoscope, Model number: GF-UE160-AL5 - Product Usage: used for endoscopic ultrasonic imaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FDF·October 16, 2020

    Olympus Ultrasound Endoscope, Model Number: GF-UCT140-AL5 - Product Usage: used with other supporting equipment for endoscopic real-time ultrasound imaging and endoscopic surgery within the gastrointestinal tract.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code ITX·October 16, 2020

    Olympus Ultrasound Endoscope, Model number: GF-UC160P-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code ODG·October 16, 2020

    Olympus Ultrasound Endoscope, Model number: GF-UCT160-OL5 - Product Usage: used for diagnostic ultrasound imaging or fluid flow analysis of the human body.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code ODG·October 16, 2020

    Olympus Ultrasound Endoscope, Model number: GF-UM130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FDS·October 16, 2020

    Olympus Ultrasound Endoscope, Model number: GF-UMQ130 - Product Usage: used with an Olympus Endoscopic Ultrasound Center, EVIS Video System Center, light source, documentation equipment, video monitor, Endo-Therapy accessories and other ancillary equipment for endoscopic ultrasound imaging of the gastrointestinal wall, biliary and pancreatic duct, and surrounding organs.

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code FDS·October 16, 2020

    cobas c 311 Analyzer, Part Number: 04826876001 In-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein and electrolyte tests. Analytes are measured photometrically or turbidimetrically; the analyzer also has an optional ISE module for measuring sodium, potassium and chloride.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JJE·October 26, 2011

    Cobas c8000 Modular Analyzer Series Cobas c502, Part Number 5964067001, a clinical chemistry analyzer intended for the in vitro quantitative / qualitative determination of analytes in body fluids.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JJE·March 13, 2014

    cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JJE·May 21, 2014

    Roche MODULAR ANALYTICS EVO Serum Work Area (SWA), Operator's Manual Software Version 08-02; Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N). Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JJE·May 21, 2014

    Cobas 8000 modular analyzer series software version 03-01, 02, 03 and 04, impacting the cobas e 602 module only. Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids. This analyzer is optimized for high throughput workloads in the professional environment using a combination of ion selective electrodes and photometric analysis modules

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JJE·April 4, 2013

    ACCU-CHEK Aviva Combo Blood Glucose Meter (as a part of the ACCU-CHEK Aviva Combo System)\ The ACCU-CHEK Combo System is indicated for the treatment of insulin-requiring diabetes and for the quantitative measurement of glucose in fresh capillary whole blood from the finger.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code NBW·October 25, 2013

    ACCU-CHEK Tender I 17/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code FPA·November 20, 2014

    Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the quantitative determination of the creatinine concentration in serum, plasma, and urine.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JJE·May 7, 2015

    Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra 800 and 400 plus systems, cobas c111, and cobas c systems for the quantitative determination of total cholesterol in serum and plasma.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code CHH·May 7, 2015

    Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use on the Hitachi systems for The quantitative determination of total cholesterol in serum and plasma.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code CHH·May 7, 2015

    Roche Elecsys Anti-CCP Immunoassay Catalog # 07251670190

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code NHX·July 16, 2019

    Tina-quant Complement C4 ver.2, Catalog 05991994190

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code DBI·August 27, 2020

    Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.

    FDA Recall
    Open, Classified ·Roche Diagnostics Operations, Inc.·Product code MMI·April 7, 2021