Abbott Molecular recalls

Abbott Molecular appears in 36 official U.S. recall notices indexed by RecallRadar, most recently on 2025-05-21.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test…
  FDA Device · Class II · 2025-05-21 · Abbott Molecular
• Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chai…
  FDA Device · Class II · 2025-05-21 · Abbott Molecular
• The Alinity m System is designed to automate the steps for nucleic acid testing
  FDA Device · Class II · 2025-04-30 · Abbott Molecular
• Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095
  FDA Device · Class II · 2024-11-06 · Abbott Molecular
• Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095
  FDA Device · Class II · 2024-11-06 · Abbott Molecular
• Alinity m System, Part Number: 08N53-002
  FDA Device · Class II · 2024-05-01 · Abbott Molecular
• Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
  FDA Device · Class III · 2024-03-06 · Abbott Molecular
• In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010
  FDA Device · Class III · 2024-03-06 · Abbott Molecular
• In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020
  FDA Device · Class III · 2024-03-06 · Abbott Molecular
• Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090
  FDA Device · Class II · 2023-12-06 · Abbott Molecular
• Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4
  FDA Device · Class II · 2023-04-12 · Abbott Molecular
• Alinity m System
  FDA Device · Class II · 2023-02-01 · Abbott Molecular
• Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
  FDA Device · Class II · 2022-12-28 · Abbott Molecular
• Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
  FDA Device · Class II · 2022-12-28 · Abbott Molecular
• Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
  FDA Device · Class II · 2022-11-30 · Abbott Molecular
• 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 Device · Class II · 2022-09-14 · Abbott Molecular
• The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
  FDA Device · Class II · 2022-08-24 · Abbott Molecular
• Alinity m HBV AMP Kit (US and CE)
  FDA Device · Class II · 2022-04-13 · Abbott Molecular
• Alinity m HBV Application Specification File (US and CE)
  FDA Device · Class II · 2022-04-13 · Abbott Molecular
• Alinity m Integrated Reaction Units (IRU)
  FDA Device · Class II · 2022-03-09 · Abbott Molecular
• Alinity m System, Part No. 08N53-002
  FDA Device · Class II · 2022-01-12 · Abbott Molecular
• Alinity m System, Part No. 08N53-002
  FDA Device · Class II · 2022-01-12 · Abbott Molecular
• Alinity m System, Part No. 08N53-002
  FDA Device · Class II · 2022-01-12 · Abbott Molecular
• Alinity m System, Part No. 08N53-002
  FDA Device · Class II · 2022-01-12 · Abbott Molecular
• Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
  FDA Device · Class I · 2021-10-20 · Abbott Molecular
• Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
  FDA Device · Class I · 2021-10-20 · Abbott Molecular
• Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diag…
  FDA Device · Class I · 2021-10-20 · Abbott Molecular
• Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
  FDA Device · Class I · 2021-10-20 · Abbott Molecular
• Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro di…
  FDA Device · Class I · 2021-10-20 · Abbott Molecular
• Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ 13…
  FDA Device · Class II · 2021-10-06 · Abbott Molecular
• The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing
  FDA Device · Class II · 2015-01-21 · Abbott Molecular
• Abbott m2000sp, an automated system for performing sample preparation for nucleic acid testing
  FDA Device · Class II · 2014-12-03 · Abbott Molecular
• 5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System)
  FDA Device · Class II · 2014-08-20 · Abbott Molecular
• The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analyte Specific Reagent (ASR) containing a single vial of CEP 8 sp…
  FDA Device · Class III · 2014-04-30 · Abbott Molecular
• Abbott m2000sp Instrument
  FDA Device · Class II · 2013-01-09 · Abbott Molecular
• Abbott Molecular Bar Code Scanner User's Guide
  FDA Device · Class II · 2012-07-25 · Abbott Molecular