BEUDAMED
    24 results · 18ms · Sources: EU EUDAMED, US FDA

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    ORAcollect RNA: ORE-100

    FDA Recall
    Open, Classified ·DNA Genotek Inc. 3000-500 Palladium Dr Kanata Canada·Product code QJR·February 18, 2022

    OPTI SARS-CoV-2 RT-PCR Test, REF Numbers: a) 99-57003 b) 99-57004

    FDA Recall
    Open, Classified ·OPTI Medical Systems, Inc·Product code QJR·June 25, 2021

    cobas SARS-CoV-2 & Influenza A/B assay cobas Liat- Reagents, 2019-Novel Coronavirus Nucleic Acid for use on the cobas Liat System, Catalog Number: 09211101190

    FDA Recall
    Open, Classified ·Roche Molecular Systems, Inc.·Product code QJR·March 25, 2021

    BD SARS-CoV-2 Reagents for BD MAX" Systems. RT-PCR test to detect SARS-CoV-2 in nasal, nasopharyngeal, oropharyngeal swab specimens, and saliva specimens.

    FDA Recall
    Open, Classified ·Becton Dickinson & Co.·Product code QJR·May 7, 2024

    ARIES SARS-CoV-2 Assay, REF: 50-10047

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code QJR·September 14, 2022

    Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code QJR·November 22, 2022

    Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic Use.

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code QJR·August 19, 2022

    Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the simultaneous qualitative detection and differentiation of RNA from SARS-CoV-2, influenza A virus (flu A), influenza B virus (flu B), and/or Respiratory Syncytial Virus (RSV) in anterior nasal or nasopharyngeal swab specimens collected by a healthcare provider (HCP), or in anterior nasal swab specimens that are self-collected at a healthcare location, from individuals suspected by their HCP of respiratory viral infection consistent with COVID-19.

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code QJR·April 28, 2025

    SIMPLEXA COVID-19 Positive Control Pack, REF MOL4160, IVD, Rx Only, UDI: (01) 20816101027051

    FDA Recall
    Open, Classified ·DiaSorin Molecular LLC·Product code QJR·September 23, 2021

    cobas Liat Analyzer: respiratory virus panel nucleic acid assay system Catalog Number: 07341920190

    FDA Recall
    Open, Classified ·Roche Molecular Systems, Inc.·Product code QJR·March 25, 2021

    CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200; BM-AD4K0200 BM-ADK0200 BM-CDK0200 BM-CFDK0200 BM-D4K0200 BM-DK0200 BM-DK0600 BM-DK0800 BM-DK1200 BM-DK1400 BM-DK1800

    FDA Recall
    Open, Classified ·GS Biomark LLC·Product code QJR·August 8, 2022

    NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs in transport medium and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider (HCP). REF Number: 300800

    FDA Recall
    Open, Classified ·NeuMoDx Molecular Inc·Product code QJR·May 15, 2023

    NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip, Ref # 300900 (marketed under EUA202947). Distributed in boxes of 6 assay strips in individual pouches. Box, pouch and strips all labeled with product name, ref #, lot #, and expiration date.

    FDA Recall
    Open, Classified ·NeuMoDx Molecular Inc·Product code QJR·January 21, 2022

    Simplexa COVID-19 Direct, REF: MOL4150; including Reaction Mix, REF: MOL4150; with previous assay definition v2

    FDA Recall
    Open, Classified ·DiaSorin Molecular LLC·Product code QJR·January 30, 2023

    Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended for the qualitative detection and differentiation of RNA from influenza A virus (flu A), influenza B virus (flu B), Respiratory Syncytial Virus (RSV), and SARS-CoV-2 in nasopharyngeal (NP) swab specimens collected by a healthcare provider, from individuals with signs and symptoms of respiratory tract infection

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code QJR·April 28, 2025

    QIAstat-Dx Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid from SARS-CoV-2 and the following organism types and subtypes: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, SARS-CoV-2, Human Metapneumovirus A+B, Influenza A, Influenza A H1, Influenza A H3, Influenza A H1N1/pdm09, Influenza B, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Rhinovirus/Enterovirus, Respiratory Syncytial Virus A+B, Bordetella pertussis, Chlamydophila pneumoniae, and Mycoplasma pneumoniae REF 691223

    FDA Recall
    Open, Classified ·Qiagen GmbH Qiagen Str. 1 Hilden Germany·Product code QJR·May 9, 2023

    ARIES SARS-CoV-2 Assay

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code QJR·July 14, 2022

    Accula SARS-CoV-2 Test, REF: COV4100

    FDA Recall
    Open, Classified ·MESA BIOTECH, INC·Product code QJR·April 6, 2022

    NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems with either of the following assays: NeuMoDx SARS CoV-2 Test Strip (REF 300800) NeuMoDx Flu A-B/RSV/SARS-CoV-2 Vantage Test Strip (REF 300900) NeuMoDx Laboratory Developed Tests (LDTs) for SARS-CoV-2 RNA detection Note: Results for targets other than SARS-CoV-2 are not impacted by this Urgent Medical Device Correction Ref. Number: 100100

    FDA Recall
    Open, Classified ·NeuMoDx Molecular Inc·Product code QJR·February 18, 2022

    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