BEUDAMED
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    Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Microgenics Corporation, located at Fremont, CA., part of Thermo Fisher Scientific The CEDIA Tobramycin II Assay is an in vitro diagnostic medical device intended for the quantitation of Tobramycin in human serum or plasma.

    FDA Recall
    Terminated ·Microgenics Corp·Product code LFW·October 16, 2013

    Pacific Hemostasis FDP Latex Reagent, REF/Model Number 100651, UDI 00845275000870, 1 x 5 mL, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company, LLC, a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA

    FDA Recall
    Terminated ·Fisher Diagnostics·Product code KQJ·May 19, 2017

    Pacific Hemostasis FDP (Fibrinogen Degradation Products) Assay Kit (30 Determinations), REF/Model 100650, UDI 00845275000863, IVD; --- Fisher Diagnostics, a division of Fisher Scientific Company LLC ,a part of Thermo Fisher Scientific Inc., Middletown, VA 22645-1905 USA --- For determination of Fibrinogen Degradation products in serum and urine.

    FDA Recall
    Terminated ·Fisher Diagnostics·Product code KQJ·May 19, 2017

    Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) samples. The Ion PGM Dx Instrument System is not intended for whole genome or de novo sequencing Product Name Installer /SKU /Updater SKU: (1) Torrent Suite Dx Software 5.14 -A52422/ A52417 (2) Torrent Suite Dx Software 5.12.5- A46166/ A46167 (3)Torrent Suite Dx Software 5.8- A36601/ A36602 (4)Torrent Suite Dx Software 5.6.4- A33178/ A33178 (5)Torrent Suite Dx Software 5.0- A29166/ A29166

    FDA Recall
    Open, Classified ·Life Technologies Corporation·Product code PFF·February 7, 2024

    Gibco DPBS, calcium, magnesium, for In-Vitro Diagnostic Use SKU 14040141

    FDA Recall
    Terminated ·Life Technologies, Corp.·Product code KIT·August 24, 2018

    Gibco GlutaMAX Supplement, for In-Vitro Diagnostic Use SKU 35050061

    FDA Recall
    Terminated ·Life Technologies, Corp.·Product code KIT·August 24, 2018

    Gibco Sodium Pyruvate (100 mM) SKU 11360070, for In-Vitro Diagnostic Use

    FDA Recall
    Terminated ·Life Technologies, Corp.·Product code KIT·August 24, 2018

    Gibco MEM Non-Essential Amino Acids Solution (100X) (SKU 11140050), for In-Vitro Diagnostic Use

    FDA Recall
    Terminated ·Life Technologies, Corp.·Product code KIT·August 24, 2018

    NeoMarkers Rabbit Monoclonal anti-Human Cyclin D1 Antibody (Clone SP4), immunochemistry Reagent and Kit, For In Vitro Diagnostic use, manufactured by Lab Vision Products, Fremont, CA, a subsidiary of ThermoFisher Scientific

    FDA Recall
    Terminated ·Lab Vision Corporation·Product code NJT·March 5, 2010

    OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests; Listeria identification sysystem

    FDA Recall
    Open, Classified ·Oxoid Australia Pty Limited 20 Dlgleish St South Australia Australia·Product code LQL·March 3, 2026

    Remel TB Potassium Permanganate (.5% Aqueous) 40192, packaged in 250 ml bottles, 5/pkg. A stain for use in qualitative procedures as a counterstain in the fluorescent microscopic detection of mycobacteria.

    FDA Recall
    Terminated ·Remel Inc·Product code JTS·October 29, 2014

    ThermoFisher Scientific Microm STP 420D automated tissue processor.

    FDA Recall
    Terminated ·Thermo Fisher Scientific·Product code IEO·June 3, 2009

    Thermo Scientific HM 550 Cold Disinfection Cryostat, Microm International GmbH, Waldorf, Germany Tissue processing equipment used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.

    FDA Recall
    Terminated ·Thermo Fisher Scientific·Product code IDP·September 23, 2010

    Thermo Scientific HM 560 Cold Disinfection Cryostat, Microm International GmbH, Waldorf, Germany Tissue processing equipment used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.

    FDA Recall
    Terminated ·Thermo Fisher Scientific·Product code IDP·September 23, 2010

    Ammonia Liquid Stable Reagent, Enzymatic Method. Catalog number TR60101. in vitro diagnostic.

    FDA Recall
    Terminated ·Thermo Fisher Scientific·Product code JIF·July 24, 2007

    Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797

    FDA Recall
    Open, Classified ·Oxoid Limited Wade Road Basingstoke United Kingdom·Product code JTN·December 23, 2024

    DRI Salicylate Serum Tox Assay, Catalog number 0977. Toxicology: The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma.

    FDA Recall
    Terminated ·Microgenics Corporation·Product code DKJ·July 25, 2016

    Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml) Manufactured by: Lab Vision Corporation, Fremont, CA Thermo Fisher Scientific Anatomical Pathology Tudor Rd., Manor Park Rancorn, Cheshire WA7 1TA UK Analyte specific reagent. It is intended for qualitative immunohistochemistry with normal and neoplastic formalin-fixed, paraffin embedded tissue sections, to be viewed by light microscopy.

    FDA Recall
    Terminated ·Lab Vision Corporation·Product code MVU·December 6, 2013

    Thermo Scientific QMS Everolimus Assay; Model number: 0380000 (US Distribution); 0373852 (Foreign Distribution) Product Usage: The QMS Everolimus Assay is intended for the quantitative determination of Everolimus, in human whole blood on automated clinical chemistry analyzers. The results obtained are used as an aid in the management of kidney and liver transplant patients receiving Everolimus therapy. This in vitro diagnostic device is intended for clinical laboratory use only. The QMS Everolimus assay is intended to be used as an aid in the management of patients receiving everolimus therapy for those organ transplant procedures indicated in the chart for each specific country.

    FDA Recall
    Terminated ·Microgenics Corporation·Product code OUF·August 15, 2016

    Thio Med w/o Ind, w/Dex (10ml) 100/PK Product Usage: Recommended for use in qualitative procedures as a general purpose media for the cultivation of aerobes and anaerobes

    FDA Recall
    Terminated ·Remel Inc·Product code JSG·April 17, 2019