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

0Oct '24 2 0 0Jan '25 0 0 1Apr 2 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 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 recalled by Abbott Molecular	Abbott Molecular	Potency & Assay	Nationwide
6 Nov 2024Device	CLASS II	Abbott Alinity m HPV AMP Kit, used recalled by Abbott Molecular	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 recalled by Abbott Molecular	Abbott Molecular	Potency & Assay	Nationwide
6 Nov 2024Device	CLASS II	Abbott Alinity m HPV AMP Kit, used recalled by Abbott Molecular	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	Hepatitis A	IL

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.