BEUDAMED
    34 results · 31ms · Sources: EU EUDAMED, US FDA

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    therascreen EGFR RGQ PCR Kit (24), Reference Number REF 870121

    FDA Recall
    Terminated ·Qiagen Sciences LLC·Product code OWG·April 8, 2020

    therascreen KRAS RGQ PCR Kit (24)-IVD qualitative PCR assay used on the Rotor-Gene Q MDx instrument for the detection of seven somatic mutations in the human KRAS oncogene REF 870021 (US IVD)

    FDA Recall
    Open, Classified ·Qiagen GmbH Qiagen Str. 1 Hilden Germany·Product code OWD·August 22, 2023

    therascreen KRAS RGQ PCR Kit (24) Model Number(s): REF 870021 (US IVD)

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code OWD·February 25, 2022

    therascreen KRAS RGQ PCR Kit (24) REF 874052 (Japan IVD, not released in the USA)

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code OWD·February 25, 2022

    therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY (alpelisib) based on a PIK3CA Mutation Detected result. REF 873121

    FDA Recall
    Terminated ·Qiagen Sciences LLC·Product code OWD·December 11, 2020

    FGFR RGQ RT-PCR Kit (RUO, not IVD) REF 8747010

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code OWD·July 20, 2022

    therascreen FGFR RGQ RT-PCR kit (US IVD) REF 874721

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code OWD·July 20, 2022

    therascreen FGFR RGQ RT-PCR Kit (CE IVD, not sold in the US) REF 874711

    FDA Recall
    Open, Classified ·Qiagen Sciences LLC·Product code OWD·July 20, 2022

    Vysis LSI ATM/p53: D13S319 /CEP 12/13q34 DNA Probe Set; fluorescence in situ hybridization (FISH) analyte specific reagents, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 05J83-001; The probe set consists of a 200 microliter vial of Vysis LSI D13S319 SO/LSI 13q34 SA/CEP 12 SG Probe, reference 30-191024, and a 200 microliter vial of Vysis LSI ATM SG/p 53 SO Probe, reference 30-191025.

    FDA Recall
    Terminated ·Abbott Molecular·Product code MVU·December 22, 2006

    Torrent Suite Dx Software Version 5.8 Catalog Number:A36601 and A36602 OEM Customer software: Torrent Suite Dx T430 Software v5.0 DARUI DR-SEQ 800 Software UDI:(01)10190302014090 (11)000000(10)5.8 (240)A36601

    FDA Recall
    Terminated ·Life Technologies Holdings Pte Ltd Blk·Product code PFF·September 26, 2019

    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

    (1) BOX LAPZD ZESTAW DO SG (2) BOX LAPISG1 ZESTAW DO SG (3) BOX LAPISGW ZESTAW DO SG Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two, triple-staggered rows. The size of the staples is determined by the selection of the 2.0 mm, 2.5 mm, 3.5 mm or 4.8 mm single use loading unit. The Endo GIA universal staplers will accommodate any of the single use loading unit sizes that are available in the 30 mm, 45 mm and 60 mm lines.

    FDA Recall
    Terminated ·COVIDIEN MEDTRONIC·Product code GDW·April 26, 2018

    Amerigel Hydrogel Saturated Gauze Dressing; 10 Individually Packaged pads size 2x2 4 Ply Pads; CAT # A5002. Wound management.

    FDA Recall
    Terminated ·Amerx Health Care Corp.·Product code MGQ·July 11, 2014

    Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm), Sterile Item Code: 3337 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic debridement process.

    FDA Recall
    Terminated ·Covidien LLC·Product code MGQ·March 3, 2017

    Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part ***Sterile***Manufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA***

    FDA Recall
    Terminated ·DeRoyal Wound Care·Product code MGQ·July 8, 2004

    Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.

    FDA Recall
    Terminated ·Amerx Health Care Corp.·Product code MGQ·July 11, 2014

    Amerigel Daily Dressing Packets Wound management

    FDA Recall
    Terminated ·Amerx Health Care Corp.·Product code MGQ·September 26, 2014

    Amerigel Daily Dressing Advanced 3-in-1 Hydrogel; 30 single used foil packets 1g. each; CAT # A2003. Wound management.

    FDA Recall
    Terminated ·Amerx Health Care Corp.·Product code MGQ·July 11, 2014

    Package Insert for TDx/TDxFLx and TDxFLx Vancomycin Reagents, REF 9523, item number 69-5726/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Laboratories HPD/ADD/GPRD·Product code LGQ·November 17, 2003

    AEROSET Phenobarbital, LN 1E08-01

    FDA Recall
    Terminated ·Abbott Laboratories Diagnostic Div·Product code LGQ·November 3, 2003