27 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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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
5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments. The Abbott m2000 RealTime System is intended for use in performing nucleic acid amplification testing by polymerase chain reaction in clinical laboratories. The system is comprised of the m2000rt and the m2000sp instruments.
FDA Enforcement
Class II
·Terminated·Abbott Molecular·August 20, 2014
Alinity m System, Part Number: 08N53-002
FDA Enforcement
Class II
·Ongoing·Abbott Molecular, Inc.·May 1, 2024
The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
FDA Enforcement
Class II
·Terminated·Abbott Molecular·January 21, 2015
Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing.
FDA Enforcement
Class II
·Terminated·Abbott Molecular·December 3, 2014
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 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
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