BEUDAMED
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    Alinity m System, Part Number: 08N53-002

    FDA Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·May 1, 2024

    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 Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·May 21, 2025

    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 Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·April 30, 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 Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·May 21, 2025

    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 Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·November 6, 2024

    Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-090; c) REF 09N17-091;

    FDA Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·November 6, 2024

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

    FDA Enforcement
    Class III ·Ongoing·Abbott Molecular, Inc.·March 6, 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 Enforcement
    Class III ·Ongoing·Abbott Molecular, Inc.·March 6, 2024

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

    FDA Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·December 28, 2022

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

    FDA Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·April 12, 2023

    Alinity m HBV Application Specification File (US and CE)

    FDA Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·April 13, 2022

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

    FDA Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·December 28, 2022

    Alinity m HBV AMP Kit (US and CE)

    FDA Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·April 13, 2022

    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 Enforcement
    Class III ·Ongoing·Abbott Molecular, Inc.·March 6, 2024

    Alinity m System, Part No. 08N53-002

    FDA Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·January 12, 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 Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·February 1, 2023

    Alinity m System, Part No. 08N53-002

    FDA Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·January 12, 2022

    Alinity m System, Part No. 08N53-002

    FDA Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·January 12, 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 Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·September 14, 2022

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

    FDA Enforcement
    Class II ·Ongoing·Abbott Molecular, Inc.·November 30, 2022