BEUDAMED
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    cobas 4800 system z480 instrument. Integrates fully automated total nucleic acid isolation directly from secondary sample tubes.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code OOI·April 1, 2013

    ARIES HSV 1&2 Assay, Catalog/REF# 50-10017

    FDA Recall
    Terminated ·Luminex Corporation·Product code OOI·November 17, 2021

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Recall
    Open, Classified ·Meridian Bioscience Inc·Product code OOI·June 22, 2022

    Roche Molecular Systems cobas x 480 System 50 mL reagent reservoir, Catalog number 05232732001. Used with the cobas CT/NG 4800 System, for in vitro diagnostics.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code OOI·March 1, 2013

    ARIES System and ARIES M1 System

    FDA Recall
    Terminated ·Luminex Corporation·Product code OOI·April 19, 2017

    Abbott m2000rt System software; an automated system for performing fluorescence-based PCR that results in quantitative and qualitative detection of nucleic acid sequences; Abbott Molecular Inc., Des Plaines, IL 60018 USA; catalog #09K15-01 The Abbott m2000rt System provides for real-time measurement of the stages of the polymerase chain reaction (PCR). Real-time PCR measures PCR amplification as it occurs, cycle-by-cycle, allowing quantitative measurements to be made during the highly reproducible exponential phase of PCR.

    FDA Recall
    Terminated ·Abbott Molecular·Product code OOI·September 8, 2011

    Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code OOI·October 12, 2022

    PANTHER FUSION System REF 9121010000 The Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Aptima assays from sample processing through amplification, detection, and data reduction. The Panther Fusion System is an integrated, fully automated, in vitro diagnostic (IVD) clinical multiplex test system. It is capable of performing nucleic acid based tests from sample processing through amplification, detection, and data reduction.

    FDA Recall
    Open, Classified ·Hologic, Inc.·Product code OOI·December 15, 2023

    Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code OOI·November 11, 2022

    BD Viper LT software, version 3.00H

    FDA Recall
    Terminated ·Bd Diagnostic·Product code OOI·December 14, 2015

    Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OOI·April 5, 2022

    Idylla INSTRUMENT, IVD, REF P0010. Intended for the detection of nucleic acid targets in various types of human samples, using disposable Test-specific ldylla Cartridges.

    FDA Recall
    Open, Classified ·Biocartis Nv B 3 Generaal De Wittelaan 11 Mechelen Belgium·Product code OOI·December 10, 2024

    BD Viper LT System, catalog number 442839 when used in conjunction with the BD ProbeTec Chlamydia trachomatis (CT) Qx Assay (cat. #442959) and the BD ProbeTec Neisseria gonorrhoeae (GC) Qx Assay (cat. #442842). In vitro diagnostic.

    FDA Recall
    Terminated ·Becton Dickinson & Co. BD Diagnostic Systems·Product code OOI·November 7, 2014

    ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OOI·February 20, 2019

    ARIES HSV 1&2 Assay, Part Number/REF 50-10017

    FDA Recall
    Terminated ·Luminex Corporation·Product code OOI·April 16, 2021

    Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840

    FDA Recall
    Open, Classified ·Meridian Bioscience Inc·Product code OOI·February 15, 2022

    Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017

    FDA Recall
    Terminated ·Luminex Corporation·Product code OOI·June 29, 2018

    Alinity m System, Part Number: 08N53-002

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code OOI·March 20, 2024

    QIAGEN Rotor Gene Q Software version 2.3.4. Real-time PCR analyzer designed for rapid thermalcycling and real-time detection of PCR assays.

    FDA Recall
    Terminated ·Qiagen Sciences LLC·Product code OOI·January 28, 2020

    Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code OOI·December 9, 2022