Abbott Molecular, Inc.

Abbott m2000sp Instrument; an automated fluid handling system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; Abbott m2000sp Instrument; an automated system for performing sample preparation for nucleic acid testing; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list 09K14 The Abbott m2000 System is intended for use in performing nucleic acid testing in clinical laboratories.

FDA Enforcement

Class II ·Terminated·Abbott Molecular·January 9, 2013

Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up the Bar Code Scanner LN 6L89-01, a component of the Abbott m2000 Instrument System; Abbott Molecular Inc., Des Plaines, IL 60018 USA; list number 06L88-02. Language configuration bar codes - Intended Use: The bar code scanner is a hand-held device that provides a convenient means of scanning sample bar codes to allow positive sample identification and is supplementary to the computer keyboard. Both the scanner and the keyboard transmit data to a System Control Center (SCC) through a single wedge (cable with branched connectors). The bar code scanner must be configured to match the keyboard language being used. In its default configuration set by the manufacturer (Jadak), the scanner is in English format. If a keyboard other than the English keyboard is being used, the user is required to use the scanner to scan an appropriate language configuration bar code provided in the User's Guide to match the language of the keyboard. Users in the U.S have the ability to convert to another language.

FDA Enforcement

Class II ·Terminated·Abbott Molecular·July 25, 2012

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

Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic

FDA Enforcement

Class I ·Terminated·Abbott Molecular, Inc.·October 20, 2021

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

Alinity m Integrated Reaction Units (IRU)

FDA Enforcement

Class II ·Terminated·Abbott Molecular, Inc.·March 9, 2022

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

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

FDA Enforcement

Class II ·Completed·Abbott Molecular, Inc.·August 24, 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 Number: 08N53-002

FDA Enforcement

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

Alinity m System, Part No. 08N53-002

FDA Enforcement

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