BEUDAMED
    21 results · 21ms · Sources: EU EUDAMED, US FDA

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    Alinity m System, Part No. 08N53-002

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code MZP·December 6, 2021

    Alinity m System, Part No. 08N53-002

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code MZP·December 6, 2021

    Alinity m System, Part No. 08N53-002

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code MZP·December 6, 2021

    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 Resp-4-Plex Amp Kit, Part Number 09N79-090

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

    Alinity m HBV AMP Kit (US and CE)

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code MKT·March 4, 2022

    Alinity m HBV Application Specification File (US and CE)

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code MKT·March 4, 2022

    Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid testing, which includes sample processing, amplification, detection, and data reduction.

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code OOI·December 9, 2022

    The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N53-002, and 08N53-032 (Refurbished).

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code OOI·March 20, 2025

    Alinity m System, Part Number: 08N53-002

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code OOI·March 20, 2024

    In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020; (2) Abbott Vysis PTEN/CEP 10 FISH Probe Kit, REF 04N62-020; (3) Abbott Vysis TelVysion 1p SpectrumGreen Probe, REF 05J03-001; (4) Abbott Vysis TelVysion 4P SpectrumGreen Probe, REF 05J03-004; (5) Abbott Vysis TelVysion 22q SpectrumOrange Probe, REF 05J04-022;

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code MVU·February 1, 2024

    In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Probe, REF 01N34-020;

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code OYU·February 1, 2024

    Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code OOI·October 12, 2022

    Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code OOI·November 11, 2022

    Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-090; c) REF 09N15-091

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code MAQ·September 12, 2024

    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

    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

    Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code OOI·February 1, 2024

    Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HCV assay is an in vitro reverse transcription-polymerase chain reaction (RT-PCR) assay for use with the automated Alinity m System to detect and quantitate hepatitis C virus (HCV) RNA in human serum or plasma.

    FDA Recall
    Open, Classified ·Abbott Molecular, Inc.·Product code MZP·October 30, 2023