Abbott Molecular, Inc.

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Top device categories

• Reagents, 2019-Novel Coronavirus Nucleic AcidQJR1,782
• Real Time Nucleic Acid Amplification SystemOOI952
• Clinical Sample ConcentratorJJH120
• Kit, Dna Detection, Human PapillomavirusMAQ95
• Test, Hiv DetectionMZF60
• Station, Pipetting And Diluting, For Clinical UseJQW31
• Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted InfectionsQEP21
• Stainer, Tissue, AutomatedKEY19
• Reagents, Specific, AnalyteMVU12
• Cytomegalovirus (Cmv) Dna Quantitative AssayPAB10

Recent recalls

• 2025-05-12Open, ClassifiedUnder Investigation by firm

  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

  There were reports of an increase in reactive negative controls and false positive results.

• 2025-05-12Open, ClassifiedUnder Investigation by firm

  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.

  There were reports of an increase in reactive negative controls and false positive results.

• 2025-04-24Open, ClassifiedDevice Design

  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).

  The design of the Alinity m System Solutions drawer enclosure may allow liquid (liquid waste or system solutions) originating in the System Solutions drawer to flow beyond the footprint of the instrument and into the walking-path of the user.

• 2024-10-29Open, ClassifiedDevice Design

  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

  Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.

• 2024-10-29Open, ClassifiedDevice Design

  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;

  Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV AMP Kit and Alinity m STI AMP Kit. Certain invalidated positive assay controls can be traced to iron leaching into the Alinity m Lysis Solution from the lysis transfer pump in the Alinity m System.

• 2024-04-19Open, ClassifiedUnder Investigation by firm

  Alinity m System, Part Number: 08N53-002

  The Alinity m System camera detects whether tubes are "capped." If the camera detects a cap and the retention bar is not present on the sample rack, the system will generate the message 'Error - 6013: Has cap, no retention bar." Abbott has identified an issue concerning the use of certain third-party Universal Transport Medium (UTM) tubes on the Alinity m System. This issue has been observed with Copan UTM-RT 3 mL Without Beads Transport & Preservation Medium for Viral Molecular Diagnostics Testing, Part Number (PN) 3C047N. However, it is possible that other third party manufactured tubes could experience the same issue.

• 2024-02-26Open, ClassifiedProcess control

  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;

  Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.

• 2024-02-26Open, ClassifiedProcess control

  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;

  Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.

• 2024-02-26Open, ClassifiedProcess control

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

  Products that were intended for export only which were not approved or registered in accordance with U.S. specifications were shipped to U.S. customers.

• 2023-11-29Open, ClassifiedOther

  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.

  Abbott has received reports of an increase in reactive negative controls and false positive results in patient samples when using the Identified Lots of Alinity m HCV AMP Kit.