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

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    Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay

    FDA Recall
    Open, Classified ·Meridian Bioscience Inc·Product code OMN·October 7, 2025

    Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay

    FDA Recall
    Open, Classified ·Meridian Bioscience Inc·Product code NJR·October 7, 2025

    Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700

    FDA Recall
    Open, Classified ·Meridian Bioscience Inc·Product code QJR·December 15, 2022

    Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal swab (NPS) specimens from individuals suspected of COVID-19

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code QJR·April 8, 2021

    Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RNA-based assay, and install the Assay Definition File (ADF) file

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code QJR·April 8, 2021

    Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300

    FDA Recall
    Open, Classified ·Meridian Bioscience Inc·Product code OZN·December 5, 2025

    illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and reads endpoint reactions.

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code OMN·April 22, 2014

    EHEC Kit Lot# 608096 Containing: Sample Diluent 18.8 ml Lot# 8602EXP.1-BUF WASH 20X II 100.0ml.Lot# 2607EXP.2-EHEC Detection Antibody 10.0ml Lot# 8603EXP.3-EHEC-Enzyme Conjugate 10.0ml Lot# 8604EXP.4-Substrate II 12.5ml Lot# 1601EXP.5-Stop-Solution II 10.0 ml Lot# 1601EXP.6-EHEC Positive Control 3.4 ml Lot# 8601EXP.7-EHEC Negative Control 3.4 ml Lot# 1603EXP.8-96 transfer pipettes-1 Microwell holder-3 Microwell strip sealers The Premier EHEC test kit is a rapid in vitro microwell EIA for the detection of Shiga Toxins I and II ( verotoxins) in stool specimens, broth cultures, from individual colonies or colony sweeps of agar plates. The Premier EHEC test is intended for use as an aid in the diagnosis of enterohemorrhagic E. Coli (EHEC) infections.

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code LFX·October 10, 2011

    meridian bioscience immunocard STAT! Rotavirus test, REF 750030, 30 tests/kit box. The ImmunoCard STAT! Rotavirus Immunoassay is a rapid in vitro qualitative procedure for the detection of rotavirus antigen in human stool. The test can be used to aid in the diagnosis of rotavirus associated gastroenteritis.

    FDA Recall
    Terminated ·MEDLINE INDUSTRIES, LP Northfield·Product code LIQ·January 25, 2022

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Recall
    Open, Classified ·Meridian Bioscience Inc·Product code OOI·June 22, 2022

    Premier brand C. difficile Toxin A, diagnstic test kits, one kit per pouch, one pouch per shipping box.

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code MCB·December 26, 2002

    Premier Toxins A & B, Diagnostic Test Kits, Catalog No. 616096.

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code LLH·September 23, 2003

    ImmunoCard toxins A & B kit, a rapid enzyme immunoassay for the detection of Clostridium difficile Toxins A and B in Stool Samples (Catalog number 712050). An in vitro diagnostic.

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code LLH·June 2, 2006

    PREMIER EHEC and PREMIER EHEC Bulk.

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code GNA·November 8, 2016

    PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrosoinal fluid (CSF).

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code MDU·December 17, 2018

    Premier brand Toxins A & B, diagnostic test kits, one kit per pouch, one pouch per shipping box.

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code MCB·December 26, 2002

    Premier CMV IgG Elisa Kits, EIA diagnostic test kits, 96 tests per kit, Catalog Numbers: 620096 and 9Z9501G.

    FDA Recall
    Terminated ·Meridian Bioscience Inc·Product code LFZ·June 18, 2003

    Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840

    FDA Recall
    Open, Classified ·Meridian Bioscience Inc·Product code OOI·February 15, 2022

    Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312

    FDA Recall
    Open, Classified ·Meridian Bioscience Inc·Product code FMH·October 19, 2023

    Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012

    FDA Recall
    Open, Classified ·Meridian Bioscience Inc·Product code IGG·October 19, 2023