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

    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

    BD Viper LT software, version 3.00H

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

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

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

    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

    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 Integrated Reaction Units (IRU)

    FDA Recall
    Terminated ·Abbott Molecular, Inc.·Product code OOI·February 11, 2022

    MagNA Pure LC 2.0 Instrument, catalog number 05197686001, Roche Diagnostics, Indianapolis, IN MagNA Pure LC 2.0 instrument is a robotic instrument for automated isolation of nucleic acids (DNA, total RNA , total viral nucleic acids) from different kinds of biological research sample material (whole blood, serum, blood cells, culture cells, tissue, bacteria, fungi) using the specially designed MagNA Pure LC kits, for the purpose of life science research only and automated filling of different kinds of PCR reaction vessels (LightCycler Capillaries, 96 well PCR plates, PCR tube strips) with PCR reaction mixes and template nucleic acid, or other reaction tubes for making of dilution series, reaction mixes.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code OOI·October 26, 2010

    cobas PCR Urine Kit 100 PKT IVD cobas PCR Female Swab Kit 100 PKT IVD cobas PCR media 100T IVD cobas PCR Female Swab Kit 100 PKT JPN-IVD Roche Molecular Systems, Inc. Branchburg, NJ 08876 USA Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250-0457 The cobas PCR media serves as a nucleic acid stabilizing transport and storage medium for gynecological specimens and is contained in the cobas PCR Female Swab Kit, cobas PCR Urine kit, and cobas PCR media 100 T kit. -The cobas PCR Urine Sample Kit is used to collect and transport urine specimens. Use this collection kit only with the cobas CT/NG Test. - The cobas PCR Female Swab Sample Kit is used to collect and transport endocervical and vaginal swab specimens. Use this collection kit only with the cobas CT/NG Test NOTE: This collection kit should not be used for collection of female urine specimens. o For endocervical swab specimens, collections are to be performed by a clinician. o For vaginal swab specimens, collections are to be performed by a clinician or by the patient (self-collection) -In US labeling, it indicates Self collection in a clinical setting. - In ex-US labeling, it indicates Clinician Instructed Self- Collection and Ensure the patient has read and understood the following self-collection instructions before providing a collection kit. - In some countries (e.g., UK), the sample collection kit is provided as self-collection for home / personal use, which may not be used in a controlled clinical setting and it is unknown if any instructions are provided. - The cobas PCR media kit is used to stabilize and transport urine specimens. Use this kit only with the cobas CT/NG Test.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code OOI·January 6, 2014

    NucliSens EasyQ Enterovirus serotype 68 v1.1: Catalog number: 200300 In Vitro Diagnostic Test

    FDA Recall
    Terminated ·bioMerieux, Inc.·Product code OOI·May 10, 2011

    Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product Usage: Usage: The Cobas KRAS Mutation Test, for use with the Cobas 4800 System, is a real-time PCR test intended for the identification of mutations in codons 12, 13 and 61 of the KRAS gene in DNA derived from formalin-fixed paraffin-embedded human colorectal cancer (CRC).

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code OOI·February 24, 2012

    TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.

    FDA Recall
    Terminated ·American Optisurgical Inc·Product code LFL·April 30, 2013

    Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·March 4, 2020

    NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius

    FDA Enforcement
    Class II ·Terminated·In2Bones, SAS·January 18, 2017

    SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius

    FDA Enforcement
    Class II ·Terminated·In2Bones, SAS·January 18, 2017

    Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180

    FDA Recall
    Terminated ·Medline Industries Inc·Product code OJH·January 21, 2020