BEUDAMED
    160 results · 49ms · Sources: EU EUDAMED, US FDA

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    VITEK 2 GP TEST KIT

    FDA Adverse Event
    Injury ·BIOMERIEUX, INC.·Product code LON·May 13, 2010

    VIDAS 30 IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BIOMERIEUX VITEK, INC.·Product code LJC·July 16, 1996

    VITEK SYSTEM

    FDA Adverse Event
    Malfunction ·BIOMERIEUX VITEK, INC.·Product code LTT·September 6, 1996

    VITEK32

    FDA Adverse Event
    Other ·BIOMERIEUX VITEK, INC·Product code LIB·January 18, 2005

    SLIDEX ROTA KIT 2

    FDA Adverse Event
    Malfunction ·BIOMERIEUX VITEK, INC.·Product code LIQ·February 5, 1998

    VITEK 2 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LTW·March 24, 2008

    VITEK® 2 ANC TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code JSP·May 30, 2017

    VITEK® 2 ANC TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code JSP·May 24, 2017

    VITEK® 2 ANC ID TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code JSP·June 1, 2017

    VITEK® 2 AST-GP67 TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC.·Product code LON·December 5, 2019

    VITEK® 2 ANC TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code JSP·June 12, 2017

    VITEK 2 GRAM-POSITIVE IDENTIFICATION TEST KIT

    FDA Adverse Event
    Injury ·BIOMERIEUX, INC·Product code LQL·July 21, 2015

    TOSOH HLC-723G8 ANALYZER G8

    FDA Adverse Event
    Malfunction ·TOSOH CORPORATION·Product code LCP·March 11, 2018

    VITEK® 2 ANC TEST KIT

    FDA Adverse Event
    Malfunction ·BIOMERIEUX, INC·Product code JSP·June 29, 2017

    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

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS W/ THERMAFIX

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DYE·April 14, 2010

    VITEK MS INSTRUMENT - 410895

    FDA Adverse Event
    Malfunction ·BIOMÉRIEUX, SA·Product code QBN·May 7, 2021

    VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieux, Inc. VITEK(R) 2 is an automated system consisting of instruments, software and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK¿ 2 utilizes growth based biochemical patterns to determine identification. The VITEK¿ 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria

    FDA Enforcement
    Class II ·Terminated·Biomerieux Inc·September 27, 2017

    VITEK 2 Gram Positive Susceptibility Test Cards (AST-P605), REF 22 325. 20 Cards/Kit. bioMerieux, Inc, Durham, North Carolina 27712. VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The VITEK 2 utilizes growth-based biochemical patterns to determine identification. The VITEK 2 provides minimal inhibitory concentration (MIC) results for most organism/drug combinations as well as a category interpretation (S, I, or R) consistent with accepted criteria. The VITEK 2 System is not considered a life supporting/sustaining device and does not deliver any type of energy or substance to the patient. The VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of Staphylococcus spp., Enterococcus spp., and S. agalactiae to antimicrobial agents when used as instructed in the Product Information manual.

    FDA Enforcement
    Class II ·Terminated·Biomerieux Inc·May 11, 2016

    VITEK 2 System, VITEK 2 XL 110V (Catalog #27227) and VITEK 2 XL 220V (Catalog #27228). VITEK 2 is an automated system consisting of instruments, software, and reagent cards designed for the identification and antimicrobial susceptibility testing of bacteria and yeast. The system is intended for use to perform in vitro diagnostic organism identification and antimicrobial susceptibility testing in human applications.

    FDA Recall
    Terminated ·Biomerieux Inc·Product code LTW·June 2, 2011