Abbott Molecular, Inc.
Des Plaines, IL
This page shows every FDA and USDA recall linked to Abbott Molecular, Inc.. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
30
Total Recalls
2021
First Recall
2025
Most Recent
Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymer...
May 12, 2025
· Device
Active
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse trans...
May 12, 2025
· Device
Active
The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in thi...
Apr 24, 2025
· Device
Active
Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17-095; b) REF 09N17-09...
Oct 29, 2024
· Device
Active
Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15-095; b) REF 09N15-0...
Oct 29, 2024
· Device
Active
Alinity m System, Part Number: 08N53-002
Apr 19, 2024
· Device
Active
In-vitro diagnostic kits:
(1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N33-020;
(2) Abbott V...
Feb 26, 2024
· Device
Active
In-vitro diagnostic kits:
(1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010;
(2) Abbott Vysis LSI...
Feb 26, 2024
· Device
Active
Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2...
Feb 26, 2024
· Device
Active
Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090.
The Alinity m HCV assay is an in vi...
Nov 29, 2023
· Device
Active
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Apr 6, 2023
· Device
Active
Alinity m System.
The Alinity m System is designed to automate the steps for nucleic acid testing, which in...
Jan 20, 2023
· Device
Active
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090
Dec 20, 2022
· Device
Active
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Dec 20, 2022
· Device
Active
Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
Nov 18, 2022
· Device
Active
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...
Aug 19, 2022
· Device
Active
The Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use.
Jul 19, 2022
· Device
Completed
Alinity m HBV Application Specification File (US and CE)
Apr 6, 2022
· Device
Active
Alinity m HBV AMP Kit (US and CE)
Apr 6, 2022
· Device
Active
Alinity m Integrated Reaction Units (IRU)
Feb 11, 2022
· Device
Terminated
Alinity m System, Part No. 08N53-002
Dec 6, 2021
· Device
Terminated
Alinity m System, Part No. 08N53-002
Dec 6, 2021
· Device
Active
Alinity m System, Part No. 08N53-002
Dec 6, 2021
· Device
Active
Alinity m System, Part No. 08N53-002
Dec 6, 2021
· Device
Active
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro...
Oct 14, 2021
· Device
Terminated
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Sp...
Oct 14, 2021
· Device
Terminated
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro...
Oct 14, 2021
· Device
Terminated
Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitr...
Oct 14, 2021
· Device
Terminated
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Spec...
Oct 14, 2021
· Device
Terminated
Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LS...
Aug 4, 2021
· Device
Terminated