BEUDAMED
    30 results · 51ms · Sources: EU EUDAMED, US FDA

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    ENDOVIVE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code KNT·September 12, 2011

    ILLUMIGENE GROUP B STREPTOCOCCUS DNA AMPLIFCATION ASSAY

    FDA Adverse Event
    Injury ·MERIDIAN BIOSCIENCE, INC.·Product code NJR·October 9, 2017

    VITEK 2 GRAM-POSITIVE IDENTIFICATION TEST KIT

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

    CLEARVIEW PBP2A SA CULTURE COLONY TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MYI·August 17, 2023

    BINAXNOW STREP PNEUMONIAE 22T (LFR)

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code GTZ·May 23, 2025

    VITEK 2 GP TEST KIT

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

    CLEARVIEW PBP2A SA CULTURE COLONY TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code MYI·August 17, 2023

    ICON DS STREP A

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GTY·May 18, 2011

    ICON DS STREP A

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GTY·May 18, 2011

    BIOFIRE® BLOOD CULTURE IDENTIFICATION 2 (BCID2) PANEL

    FDA Adverse Event
    Malfunction ·BIOFIRE DIAGNOSTICS, LLC·Product code PAM·May 15, 2025

    PICC/ CVC SECURE 20/CS

    FDA Adverse Event
    Injury ·MEDICAL ACTION INDUSTRIES·Product code PEZ·February 23, 2022

    UNKNOWN

    FDA Adverse Event
    Malfunction ·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code LSL·May 10, 2023

    TRUCOLOR WRIGHT'S GIEMSA STAIN KIT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code KQC·August 19, 2011

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·July 15, 2021

    ACCELERATE PHENO SYSTEM, ACCELERATE PHENOTEST BC KIT

    FDA Adverse Event
    Malfunction ·ACCELERATE DIAGNOSTICS, INC.·Product code PRH·October 23, 2019

    PICC/ CVC SECURE

    FDA Adverse Event
    Injury ·MEDICAL ACTION INDUSTRIES·Product code PEZ·February 23, 2022

    Verigene BC-GN Test Kit (Catalog number 20-005-021) includes: 1) 20 Verigene BC-GN Test Cartridges. Each Test Cartridge comes preloaded with all required reaction solutions, including wash solutions, oligonucleotide probe solution and signal amplification solutions required to generate a test result. BC-GN is indicated for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of bacterial bloodstream infections; however, is not used to monitor these infections.

    FDA Enforcement
    Class II ·Terminated·Nanosphere, Inc.·August 20, 2014

    ProbeChek Vysis UroVysion Control Slides, for Fluorescence in situ Hybridization (FISH) using Vysis UroVysion Bladder Recurrence Kit; an invitro diagnostic; fixed, cultured normal human male lymphoblast cell line (negative target) and fixed culture human bladder carcinoma cell line specimens (positive), applied to glass microscope slides; catalog #30-805070, 3 slides per kit; Vysis, Inc., Downers Grove, IL 60515 USA

    FDA Recall
    Terminated ·Vysis·Product code MMW·February 19, 2004

    Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

    FDA Enforcement
    Class II ·Terminated·Princeton Biomeditech Corp·September 12, 2012

    CARDIAC/PERITONEAL CATHETER, STANDARD, BARIUM IMPREGNATED, 90 CM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·May 26, 2021