BEUDAMED
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    Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due to being purchased with or later used to convert to ACGO.

    FDA Recall
    Open, Classified ·Datex-Ohmeda, Inc.·Product code BSZ·July 12, 2024

    Biomeme SARS-CoV-2- Real Time RT-PCR Test, Instructions for Use, Part number 100002824 Subcomponent of: SARS-CoV-2 Go-Strips, 3000555; SARS-CoV-2 Go-Plates, 3000562; SARS-Cov-2 Bulk Vials, 3000564

    FDA Recall
    Terminated ·Biomeme, Inc.·Product code QJR·October 20, 2021

    Tobra Full Dose CE Antibiotic Simplex P- Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number:6197-1-001

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code LOD·November 7, 2022

    Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of prostheses to living bone in orthopaedic Catalog Number: 6191-0-001

    FDA Recall
    Open, Classified ·Howmedica Osteonics Corp.·Product code LOD·November 7, 2022

    OttLite Rechargeable UVC Disinfecting Wand

    FDA Recall
    Open, Classified ·Ottlite TEchnologies, Inc.·Product code RHP·November 17, 2022

    Access 2 Immunoassay Analyzer, Catalog Number 81600N

    FDA Recall
    Open, Classified ·Beckman Coulter, Inc.·Product code JJE·February 5, 2025

    The Hero Model 100 (H-100) is a system consisting of a smart pill dispenser and a medication management app.

    FDA Recall
    Terminated ·Hero Health·Product code NXB·July 2, 2021

    t:connect mobile app used in conjunction with t:slim X2 insulin pump with Control-IQ technology

    FDA Recall
    Open, Classified ·Tandem Diabetes Care, Inc.·Product code QFG·March 5, 2024

    Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791RD (Red)

    FDA Recall
    Open, Classified ·Medical Depot Inc.·Product code ITJ·June 14, 2024

    The Biomeme SARS-CoV-2 Real-Time RT-PCR Test is a molecular in vitro diagnostic test that is based on widely used nucleic acid amplification technology. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test contains primers and probes and internal controls used in RT-PCR for the in vitro qualitative detection of SARS-CoV-2 RNA in upper respiratory specimens. The Biomeme SARS-CoV-2 Real-Time RT-PCR Test utilizes Biomemes M1 Sample Prep Cartridge for RNA extraction, Biomemes SARS-CoV-2 Go-Strips assay, and Biomemes portable Franklin" Real-Time qPCR Thermocycler. Franklins companion mobile app, Biomeme Go, scans tests, runs PCR experiments online or offline, and is used to quickly interpret your test results while conveniently syncing data to the Biomeme Cloud. Biomeme: 1000013 (Android Smartphone w/ Biomeme Go Mobile App) and Biomeme: 1000012 (Rugged Android Smartphone w/ Biomeme Go Mobile App) are controller for Biomeme Franklin thermocycler.

    FDA Recall
    Terminated ·Biomeme, Inc.·Product code QJR·October 23, 2020

    Nitro Glide Knee Walker-offers users recovering from a below-the-knee injury the ability to remain mobile and glide through their daily activities. Model: 791BL (Blue)

    FDA Recall
    Open, Classified ·Medical Depot Inc.·Product code ITJ·June 14, 2024

    Resin UPDATE CD-ROM, REF: 250-3020 inside VARIANTnbs Sickle Cell Program Reorder Pack, REF: 250-3000

    FDA Recall
    Open, Classified ·Bio-Rad Laboratories, Inc.·Product code GKA·April 7, 2022

    Hypoguard Advance Blood Glucose Strips, 10, 50, and 100 strip bottles.

    FDA Recall
    Terminated ·Hypoguard USA, Inc.·Product code CGA·November 26, 2003

    LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037

    FDA Recall
    Terminated ·Lifescan Inc·Product code CGA·November 17, 2003

    ACCU-CHEK Comfort Curve, Cat. No. 2139634. Ref. numbers 03856348001 and 12139642001 both with meter model number 2138930.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CGA·June 22, 2006

    AccuData GTS Plus AccuData GTS For Blood Glucose Monitoring and Automated Data Management, contents Accu-Chek Advantage repalcement Meter and module, cat. no. 454; Ref. no. 03144798001 contains meter model no. 777.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CGA·June 22, 2006

    ACCU-CHEK Advantage Blood Glucose Meter, Cat. No. 3332586; Ref. no. 03332586001 with meter model no. 2138930.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CGA·June 22, 2006

    ACCU-CHEK Advantage FPO Diabetes Monitoring Kit, Cat. no. 3271358001. Ref. no. 03271358001 with meter model no. 3288650.

    FDA Recall
    Terminated ·Roche Diagnostics Corp.·Product code CGA·June 22, 2006

    Martel Printer Accessory to i-STAT Portable Clinical Analyzer, rechargeable battery pack. Printing results of clinical chemistry tests and test panels contained in the i-STAT test cartridges.

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code CGA·April 22, 2009

    GCX Mountable Downloader-Recharger; (accessory to the i-STAT Portable Clinical Analyzer (model 300). The GCX Mountable Downloader-Recharger (GCX) is a connectivity component that is intended to be mounted to a GCX compatible mount or "arm" and provide a data connection to an authorized manufacturer's patient monitoring systems.

    FDA Recall
    Terminated ·Abbott Point of Care Inc.·Product code CGA·August 20, 2010