BEUDAMED
    14 results · 9ms · Sources: EU EUDAMED, US FDA

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    Liko Universal Twinbar 670 QRH, an accessory that can be used together with most Liko lifts, model numbers 3156087 and P3156087.

    FDA Recall
    Open, Classified ·Baxter Healthcare Corporation·Product code FSA·February 21, 2022

    GE Nuclear Medicine 600/800 series systems, specifically: a) 850, b) 850 / Dismount, c) 850 3/8 inch NM Gantry, d) 860 / Dismount, e) 860 3/8 inch NM Gantry, f) 860 5/8 inch NM Gantry, g) 860 BJ, h) NM 830 3/8 inch BJ, i) NM/CT 850 3/8 inch BJ, j) NM/CT 850 3/8 inch ROW, k) NM/CT 850 3/8 inch ROW_, l) NM/CT 850 CT 850 3/8 inch, m) NM/CT 850 ES 3/8 inch, n) NM/CT 850 ES 3/8 inch ROW, o) NM/CT 860 3/8 inch, p) NM/CT 860 3/8 inch BJ, q) NM/CT 860 3/8 inch ROW, r) NM/CT 860 ADVANCE, s) NM/CT 860 advance 3/8 inch NM Gantry, t) NM/CT 860 BEYOND, u) NM/CT 860 beyond 3/8 inch NM Gantry, v) NM/CT 860 China for China, w) NM/CT 860 CT 860 3/8 inch, x) NM/CT 860 ES 3/8 inch, y) NM/CT 860 ES 3/8 inch ROW, z) NM/CT 850 3/8 inch, aa) NM/CT 850 ES 3/8 inch ROW, bb) NM/CT 860 3/8 inch CH, cc) XELERIS 4 DR WORKSTATION; Emission Computed Tomography System

    FDA Recall
    Open, Classified ·GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 4, Hayozma St Tirat Carmel Israel·Product code KPS·December 19, 2022

    PCRopsis Reagent RVD with RVD Enhancer: a) 1 mL, VALIDATION USE ONLY, REF 78336001; b) 25 mL, REF 78336025; c) 100 mL, REF 78336100; Extraction-free PCR from saliva, urine, &swab specimens in transport medium, nucleic acid extraction from a variety of biological samples

    FDA Recall
    Open, Classified ·Entopsis Inc.·Product code JJH·February 21, 2023

    PCRopsis Activator: a) 1.5mL, REF 228001; b) 0.5mL,REF 228002; nucleic acid extraction from a variety of biological samples

    FDA Recall
    Open, Classified ·Entopsis Inc.·Product code JJH·February 21, 2023

    PCRopsis Reagent Buccal, IVD, REF 282001; Extraction-free PCR from bucca; swabs (no transport medium) ,nucleic acid extraction from a variety of biological samples

    FDA Recall
    Open, Classified ·Entopsis Inc.·Product code JJH·February 21, 2023

    EZ2 Connect MDx-IVD Designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model Number: 9003230

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code JJH·March 4, 2024

    QIAcube Connect MDx - IVD Instrument designed to perform automated isolation and purification of nucleic acids in molecular diagnostic and/or molecular biology applications. Model/Catalog Number: 900370 Software Version: 1.0.1

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code JJH·June 3, 2024

    QIAcube Connect MDx, Model No. 9003070

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code JJH·November 21, 2021

    PCRopsis Reagent RVD-RT, IVD: a) 1 mL, REF 78378001; b) 25 mL, REF 78378025; c) 100 mL, REF 78378100; Extraction-free PCR at room temperature; nucleic acid extraction from a variety of biological samples

    FDA Recall
    Open, Classified ·Entopsis Inc.·Product code JJH·February 21, 2023

    PCRopsis Support: a) 1 mL, REF 787001; b) 0.25 mL, REF 787002; c) 25 uL, REF 787003; Improves the functionality of PCRopsis regents for select applications; nucleic acid extraction from a variety of biological samples

    FDA Recall
    Open, Classified ·Entopsis Inc.·Product code JJH·February 21, 2023

    PCRopsis Lysis Beads, IVDD: a) 25 tubes , REF 597000; b) 25 tubes, REF 597825; c) 50 tubes, REF 597850; d) 25 grams, REF 5970025; e) 1000 kilogram, REF 5971000; coated beads that facilitate lysis of microorganisms; nucleic acid extraction from a variety of biological samples

    FDA Recall
    Open, Classified ·Entopsis Inc.·Product code JJH·February 21, 2023

    QIAsymphony SP SOW 5.0.3, software used with the QIAsymphony SP Instrument (The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids-IVD) Model Number: 9001297 Product Usage: The QIAsymphony SP instrument is designed to perform automated purification of nucleic acids. It is intended to be used only in combination with QIAsymphony kits indicated for use with the QIAsymphony SP for the applications described in the kit handbooks. The QIAsymphony SP is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the QIAsymphony SP instrument

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code JJH·July 2, 2019

    The FAST System and the FAST PBC Prep Cartridge together are a closed, rapid and automated sample preparation system for isolating bacterial cells directly from a positive blood culture (PBC). The cartridge and instrument isolate and concentrate bacterial cells directly from PBC by removing blood, cellular and culture media matrix components from the sample, thereby reducing the sample volume considerably while maintaining bacterial cell viability. The resulting material is a purified microbial suspension or Liquid Colony for use in downstream in vitro diagnostics.

    FDA Recall
    Open, Classified ·Qvella Corporation·Product code JJH·November 2, 2022

    PCRopsis BCSNano (1mL), REF 2276001; nucleic acid extraction from a variety of biological samples

    FDA Recall
    Open, Classified ·Entopsis Inc.·Product code JJH·February 21, 2023