Abbott Molecular, Inc.
20 recalls on record · Latest: May 21, 2025
FDA Devices Moderate May 21, 2025
Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) test intended …
FDA Devices Moderate May 21, 2025
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase chain reaction…
FDA Devices Moderate Apr 30, 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 …
FDA Devices Moderate Nov 6, 2024
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 Devices Moderate Nov 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 Devices Moderate May 1, 2024
Alinity m System, Part Number: 08N53-002
FDA Devices Low Mar 6, 2024
Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
FDA Devices Low Mar 6, 2024
In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2) Abbott Vysis LSI D13S319 (13q14.3) SpectrumOrange Pro…
FDA Devices Moderate Apr 12, 2023
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
FDA Devices Moderate Dec 28, 2022
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
FDA Devices Moderate Nov 30, 2022
Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
FDA Devices Moderate Apr 13, 2022
Alinity m HBV AMP Kit (US and CE)
FDA Devices Moderate Mar 9, 2022
Alinity m Integrated Reaction Units (IRU)
FDA Devices Moderate Jan 12, 2022
Alinity m System, Part No. 08N53-002
FDA Devices Critical Oct 20, 2021
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
FDA Devices Critical Oct 20, 2021
Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
FDA Devices Critical Oct 20, 2021
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
FDA Devices Critical Oct 20, 2021
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
FDA Devices Critical Oct 20, 2021
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
FDA Devices Moderate Oct 6, 2021