20 results
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44ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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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 Enforcement
Class II
·Terminated·Meridian Bioscience Inc·July 9, 2014
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
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
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
Premier Platinum brand HpSA, diagnostic test kits, one kit per pouch, one pouch per shipping box.
FDA Recall
Terminated
·Meridian Bioscience Inc·Product code LYR·December 26, 2002
The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.
FDA Recall
Terminated
·Meridian Bioscience Inc·Product code LJZ·February 8, 2021
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 Enforcement
Class II
·Terminated·Meridian Bioscience Inc·January 23, 2019
PREMIER EHEC and PREMIER EHEC Bulk.
FDA Enforcement
Class II
·Terminated·Meridian Bioscience Inc·January 25, 2017
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 Enforcement
Class II
·Terminated·Meridian Bioscience Inc·May 19, 2021
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 Enforcement
Class II
·Terminated·Meridian Bioscience Inc·May 19, 2021
The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.
FDA Enforcement
Class II
·Terminated·Meridian Bioscience Inc·March 31, 2021