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Abbott Molecular, Inc.

22 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Alinity m Resp-4-Plex Amplification (AMP) Kit (CE), List Number 09N79-090, a multiplex rea recall (Z-1748-2025)Abbott Molecular, Inc.2025-05-12
Alinity m Resp-4-Plex AMP Kit, List Number 09N79-096, a multiplex real-time reverse transc recall (Z-1749-2025)Abbott Molecular, Inc.2025-05-12
The Alinity m System is designed to automate the steps for nucleic acid testing. Model Num recall (Z-1665-2025)Abbott Molecular, Inc.2025-04-24
Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: a) REF 09N15- recall (Z-0233-2025)Abbott Molecular, Inc.2024-10-29
Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: a) REF 09N17- recall (Z-0234-2025)Abbott Molecular, Inc.2024-10-29
Alinity m System, Part Number: 08N53-002 recall (Z-1602-2024)Abbott Molecular, Inc.2024-04-19
In-vitro diagnostic kits: (1) Abbott Vysis MDM2 / CEP 12 FISH Probe Kit, REF 01N15-010; (2 recall (Z-1188-2024)Abbott Molecular, Inc.2024-02-26
In-vitro diagnostic kits: (1) Abbott Vysis LSI ATM (11q22.3) SpectrmOrange Probe, REF 01N3 recall (Z-1189-2024)Abbott Molecular, Inc.2024-02-26
Wash station: M1000 Wash Station Assembly & DITI Slide, REF 04J72-28* (*This part number i recall (Z-1190-2024)Abbott Molecular, Inc.2024-02-26
Alinity m HCV AMP kit, List (REF) Numbers: a) 08N50-095 and b) 08N50-090. The Alinity m HC recall (Z-0407-2024)Abbott Molecular, Inc.2023-11-29
Abbott Alinity m System, REF 08N53-002, containing Amplification Detetction Unit (ADU) #4. recall (Z-1349-2023)Abbott Molecular, Inc.2023-04-06
Alinity m System. The Alinity m System is designed to automate the steps for nucleic acid recall (Z-1009-2023)Abbott Molecular, Inc.2023-01-20
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-096 recall (Z-0739-2023)Abbott Molecular, Inc.2022-12-20
Abbott Alinity m Resp-4-Plex Amp Kit, Part Number 09N79-090 recall (Z-0740-2023)Abbott Molecular, Inc.2022-12-20
Alinity m System, REF 08N53-002, For In Vitro Diagnostic Use recall (Z-0268-2023)Abbott Molecular, Inc.2022-11-18
Alinity m HBV Application Specification File (US and CE) recall (Z-0883-2022)Abbott Molecular, Inc.2022-04-06
Alinity m HBV AMP Kit (US and CE) recall (Z-0884-2022)Abbott Molecular, Inc.2022-04-06
Alinity m SARS-CoV-2 Amp Kit (Emergency Use Authorization, US Assay) and Alinity m SARS-Co recall (Z-0004-2022)Abbott Molecular, Inc.2021-10-14
Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4 recall (Z-0005-2022)Abbott Molecular, Inc.2021-10-14
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specifica recall (Z-0006-2022)Abbott Molecular, Inc.2021-10-14
Alinity m SARS-CoV-2 Amp Kit (Non-US Assay) and Alinity m SARS-CoV-2 Application Specifica recall (Z-0007-2022)Abbott Molecular, Inc.2021-10-14
Alinity m Resp-4-Plex AMP Kit (Non-US Assay) and Alinity m Resp-4-Plex Application Specifi recall (Z-0008-2022)Abbott Molecular, Inc.2021-10-14

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