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Abbott Molecular, Inc. Recalls

18 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Abbott Molecular, Inc..

18Total Recalls
4Critical
194,378Units Affected
Apr 28, 2025Most Recent
All Recalls

Every Abbott Molecular, Inc. Recall

Sorted by most recent. Click any recall for full details.

18 recalls
High RiskFDA
Abbott Molecular, Inc.
Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transcription (RT) polymerase chain reaction (PCR) te...
Medical Implants·656 affected·Apr 28, 2025
High RiskFDA
Abbott Molecular, Inc.
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex real-time reverse transcription (RT) polymerase ch...
Respiratory Devices·1,447 affected·Apr 28, 2025
High RiskFDA
Abbott Molecular, Inc.
The Alinity m System is designed to automate the steps for nucleic acid testing. Model Numbers included in this recall are 08N53-001, 08N...
Medical Devices·0 affected·Mar 20, 2025
High RiskFDA
Abbott Molecular, Inc.
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
Medical Devices·13,318 affected·Sep 12, 2024
High RiskFDA
Abbott Molecular, Inc.
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;
Medical Devices·15,068 affected·Sep 12, 2024
High RiskFDA
Abbott Molecular, Inc.
Alinity m System, Part Number: 08N53-002
Medical Devices·1,012 affected·Mar 20, 2024
RecallFDA
Abbott Molecular, Inc.
Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number is a spare to the M2000sp.)
Medical Devices·0 affected·Feb 1, 2024
High RiskFDA
Abbott Molecular, Inc.
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096
Medical Devices·3,896 affected·Nov 22, 2022
High RiskFDA
Abbott Molecular, Inc.
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4.
Medical Devices·1 affected·Nov 11, 2022
High RiskFDA
Abbott Molecular, Inc.
Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use
Diagnostic Devices·883 affected·Oct 12, 2022
High RiskFDA
Abbott Molecular, Inc.
Alinity m HBV AMP Kit (US and CE)
Medical Devices·4,966 affected·Mar 4, 2022
High RiskFDA
Abbott Molecular, Inc.
Alinity m Integrated Reaction Units (IRU)
Medical Devices·3,063 affected·Feb 11, 2022
High RiskFDA
Abbott Molecular, Inc.
Alinity m System, Part No. 08N53-002
Medical Devices·742 affected·Dec 6, 2021
CriticalFDA
Abbott Molecular, Inc.
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Diagnostic Devices·11,408 affected·Sep 2, 2021
CriticalFDA
Abbott Molecular, Inc.
Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic
Diagnostic Devices·5,855 affected·Sep 2, 2021
CriticalFDA
Abbott Molecular, Inc.
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro d...
Diagnostic Devices·60,563 affected·Sep 2, 2021
CriticalFDA
Abbott Molecular, Inc.
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specification File. in vitro diagnostic
Diagnostic Devices·71,314 affected·Sep 2, 2021
High RiskFDA
Abbott Molecular, Inc.
Vysis CLL FISH Probe Kit with the following components: Vysis LSI p53 SpectrumOrange/ATM, SpectrumGreen and LSI D13S319, SpectrumOrange/ ...
Medical Devices·186 affected·Aug 4, 2021