Abbott Molecular recalls

Abbott Molecular has 36 recalls on record with the FDA and USDA, the earliest in 2012 and the latest reported on 21 May 2025. 20 are still ongoing.

Total recalls36since 2012

Last 12 months0reported

Class I514% of total

Ongoing20latest 21 May 2025

Recalls per month, last 24 months

click a bar for that month

2Nov '24 0 0 0Feb 0 1 2May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 5 14%Class II 27 75%Class III 4 11%

Why abbott molecular is recalled

Product types

By year

202538%
2024617%
202338%
20221233%
2021617%
201513%
201438%
201313%
201213%

Ongoing abbott molecular recalls

20 active

Reported	Class	Recall	Company	Reason	Where
21 May 2025Device	CLASS II	Alinity m Resp-4-Plex Amplification (AMP) Kit (CE) recalled	Abbott Molecular	Other	Nationwide
21 May 2025Device	CLASS II	Alinity m Resp-4-Plex AMP Kit, List Number 09N79 recalled	Abbott Molecular	Other	Nationwide
30 Apr 2025Device	CLASS II	The Alinity m System is designed to automate the steps recalled	Abbott Molecular	Other	Nationwide
6 Nov 2024Device	CLASS II	Abbott Alinity m STI AMP Kit, used with the Alinity m System recalled	Abbott Molecular	Potency & Assay	Nationwide
6 Nov 2024Device	CLASS II	Abbott Alinity m HPV AMP Kit, used with the Alinity m System recalled	Abbott Molecular	Potency & Assay	Nationwide
1 May 2024Device	CLASS II	Alinity m System recalled by Abbott Molecular	Abbott Molecular	Other	Nationwide

All abbott molecular recalls, newest first

36 total

Reported	Class	Recall	Company	Reason	Where
21 May 2025Device	CLASS II	Alinity m Resp-4-Plex Amplification (AMP) Kit (CE) recalled	Abbott Molecular	Other	Nationwide
21 May 2025Device	CLASS II	Alinity m Resp-4-Plex AMP Kit, List Number 09N79 recalled	Abbott Molecular	Other	Nationwide
30 Apr 2025Device	CLASS II	The Alinity m System is designed to automate the steps recalled	Abbott Molecular	Other	Nationwide
6 Nov 2024Device	CLASS II	Abbott Alinity m STI AMP Kit, used with the Alinity m System recalled	Abbott Molecular	Potency & Assay	Nationwide
6 Nov 2024Device	CLASS II	Abbott Alinity m HPV AMP Kit, used with the Alinity m System recalled	Abbott Molecular	Potency & Assay	Nationwide
1 May 2024Device	CLASS II	Alinity m System recalled by Abbott Molecular	Abbott Molecular	Other	Nationwide
6 Mar 2024Device	CLASS III	In-vitro diagnostic kits: Abbott Vysis LSI ATM recalled	Abbott Molecular	Hidden Drug Ingredients	Nationwide
6 Mar 2024Device	CLASS III	In-vitro diagnostic kits: Abbott Vysis / CEP 12 FISH Probe Kit recalled	Abbott Molecular	Hidden Drug Ingredients	Nationwide
6 Mar 2024Device	CLASS III	Wash station: M1000 Wash Station Assembly & DITI Slide recalled	Abbott Molecular	Hidden Drug Ingredients	Nationwide
6 Dec 2023Device	CLASS II	Alinity m HCV AMP kit, List recalled by Abbott Molecular	Abbott Molecular	Potency & Assay	IL
12 Apr 2023Device	CLASS II	Abbott Alinity m System recalled by Abbott Molecular	Abbott Molecular	Other	PA
1 Feb 2023Device	CLASS II	Alinity m System recalled by Abbott Molecular	Abbott Molecular	Other	IL
28 Dec 2022Device	CLASS II	Abbott Alinity m Resp-4-Plex Amp Kit recalled by Abbott Molecular	Abbott Molecular	Other	IL
28 Dec 2022Device	CLASS II	Abbott Alinity m Resp-4-Plex Amp Kit recalled by Abbott Molecular	Abbott Molecular	Other	IL
30 Nov 2022Device	CLASS II	Alinity m System recalled by Abbott Molecular	Abbott Molecular	Device Malfunction	IL
14 Sep 2022Device	CLASS II	Abbott Alinity m Sars-CoV-2 Ctrl Kit recalled by Abbott Molecular	Abbott Molecular	Other	24 states
24 Aug 2022Device	CLASS II	The Alinity m System recalled by Abbott Molecular	Abbott Molecular	Other	IL
13 Apr 2022Device	CLASS II	Alinity m HBV Application Specification File (US and CE) recalled	Abbott Molecular	Other	14 states
13 Apr 2022Device	CLASS II	Alinity m HBV AMP Kit (US and CE) recalled by Abbott Molecular	Abbott Molecular	Other	14 states
9 Mar 2022Device	CLASS II	Alinity m Integrated Reaction Units (IRU) recalled by Abbott Molecular	Abbott Molecular	Other	Nationwide
12 Jan 2022Device	CLASS II	Alinity m System recalled by Abbott Molecular	Abbott Molecular	Other	16 states
12 Jan 2022Device	CLASS II	Alinity m System recalled by Abbott Molecular	Abbott Molecular	Device Malfunction	IL
12 Jan 2022Device	CLASS II	Alinity m System recalled by Abbott Molecular	Abbott Molecular	Device Malfunction	Nationwide
12 Jan 2022Device	CLASS II	Alinity m System recalled by Abbott Molecular	Abbott Molecular	Other	Nationwide
20 Oct 2021Device	CLASS I	Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization recalled	Abbott Molecular	Potency & Assay	Nationwide
20 Oct 2021Device	CLASS I	Alinity m Sars-CoV-2 Amp Kit (Non-US Assay) recalled by Abbott Molecular	Abbott Molecular	Potency & Assay	Nationwide
20 Oct 2021Device	CLASS I	Alinity m Sars-CoV-2 Amp Kit (Emergency Use Authorization recalled	Abbott Molecular	Potency & Assay	Nationwide
20 Oct 2021Device	CLASS I	Alinity m Resp-4-Plex AMP Kit (Non-US Assay) recalled	Abbott Molecular	Potency & Assay	Nationwide
20 Oct 2021Device	CLASS I	Alinity m Sars-CoV-2 Amp Kit (Non-US Assay) recalled by Abbott Molecular	Abbott Molecular	Potency & Assay	Nationwide
6 Oct 2021Device	CLASS II	Vysis CLL FISH Probe Kit with the following components recalled	Abbott Molecular	Other	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.