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    43 results · 17ms · Sources: EU EUDAMED, US FDA

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    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

    PENTRA 120 and PENTRA 120 Retic Hematology Analyzer

    FDA Recall
    Terminated ·ABX Diagnostics Inc·Product code GJH·June 24, 2004

    Minicon Clinical Sample Concentrators for In Vitro Diagnostic Use 9031 (Model: Minicon B-15) & 9051 (Model: Minicon CS-15) Minicon concentrators are non-sterile, disposable, multiwall ultrafiltration devices. Minicon clinical sample concentrators are for in vitro diagnostic use and are intended for concentrating serum, urine, cerebrospinal fluid, and other body fluids prior to analysis.

    FDA Recall
    Terminated ·Merck Millipore Ltd. Tullagreen Carrigtwohill County Cork Ireland·Product code JJH·May 14, 2018

    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

    Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14 The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories.

    FDA Recall
    Terminated ·Abbott Molecular·Product code JJH·December 4, 2012

    Kit BD Max ExK DNA 1 USA; Catalog # 442817

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JJH·July 17, 2019

    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

    EZ1 DSP Virus Kit (48), IVD, REF 62724 intended for in vitro diagnostic use.

    FDA Recall
    Terminated ·QIAGEN 19300 GERMANTOWN RD GERMANTOWN MD 20874 USA KOELN Germany·Product code JJH·May 28, 2018

    Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.

    FDA Recall
    Terminated ·Abbott Molecular·Product code JJH·October 23, 2014

    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

    MagNA Pure 96 System Version 1.0 Software Version 2.0 Robotic workstation for automated isolation of nucleic acids from different kinds of crude sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) by the use of the specially designed MagNA Pure reagent kits, automated filling of different kinds of PCR reaction vessels.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code JJH·November 25, 0013

    eMAG System, Ref 418591 It is an In Vitro Diagnostic Medical device intended for the automated isolation (purification and concentration) of total nucleic acids (RNA/DNA) from biological specimens, with liquid and homogeneous properties (as part of their natural characteristics or after pre-treatment).

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code JJH·April 10, 2017

    Kit BD Max ExK DNA 2 USA; Catalog # 442819

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JJH·July 17, 2019

    Filter-Tips, 1500 ul (1024 tips/kitbox), REF 997024- REF: 997024 IVD: Used with the QIAGEN QIAsymphony SP/AS Instruments (REF 9001297 and 9001301) REF: 997024 Used in sample preparation

    FDA Recall
    Terminated ·Qiagen Sciences LLC·Product code JJH·June 5, 2019

    MagNA Pure 96 Instrument, clinical sample concentrator, Material number 06541089001 - Product Usage: This protocol is intended for pipetting samples into a MagNA Pure 96 Processing Cartridge (purification rack position 1) before a purification run.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code JJH·June 3, 2020

    The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.

    FDA Recall
    Terminated ·Abbott Molecular·Product code JJH·November 23, 2013

    Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14

    FDA Recall
    Terminated ·Abbott Molecular·Product code JJH·October 11, 2011