Meridian Bioscience recalls

Meridian Bioscience has 15 recalls on record with the FDA and USDA, the earliest in 2014 and the latest reported on 14 Jan 2026. 9 are still ongoing. 3 were reported in the last 12 months. The most frequent reason is foreign material.

Total recalls15since 2014

Last 12 months3reported

Class I00% of total

Ongoing9latest 14 Jan 2026

Recalls per month, last 24 months

click a bar for that month

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

Severity split

Class I 0 0%Class II 15 100%Class III 0 0%

Why meridian bioscience is recalled

Product types

Test Kits & Diagnostics960%
Other Medical Devices640%

By year

202617%
2025213%
2023427%
2022213%
2021320%
201917%
201717%
201417%

Ongoing meridian bioscience recalls

9 active

Reported	Class	Recall	Company	Reason	Where
14 Jan 2026Device	CLASS II	Revogene C. difficile, in vitro diagnostic assay intended recalled	Meridian Bioscience	Potency & Assay	Nationwide
26 Nov 2025Device	CLASS II	Group B Streptococcus recalled by Meridian Bioscience	Meridian Bioscience	Foreign Material	14 states
26 Nov 2025Device	CLASS II	alethia c. Difficile recalled by Meridian Bioscience	Meridian Bioscience	Foreign Material	14 states
20 Dec 2023Device	CLASS II	Para-Pak Clean Vial-For the collection, transportation recalled	Meridian Bioscience	Foreign Material	Nationwide
20 Dec 2023Device	CLASS II	Para-Pak Zn-PVA/10% Formalin-for the routine collection recalled	Meridian Bioscience	Foreign Material	Nationwide
20 Dec 2023Device	CLASS II	Cardinal Health Clean Stool Transportation System recalled	Meridian Bioscience	Packaging Defects	Nationwide

All meridian bioscience recalls, newest first

15 total

Reported	Class	Recall	Company	Reason	Where
14 Jan 2026Device	CLASS II	Revogene C. difficile, in vitro diagnostic assay intended recalled	Meridian Bioscience	Potency & Assay	Nationwide
26 Nov 2025Device	CLASS II	Group B Streptococcus recalled by Meridian Bioscience	Meridian Bioscience	Foreign Material	14 states
26 Nov 2025Device	CLASS II	alethia c. Difficile recalled by Meridian Bioscience	Meridian Bioscience	Foreign Material	14 states
20 Dec 2023Device	CLASS II	Para-Pak Clean Vial-For the collection, transportation recalled	Meridian Bioscience	Foreign Material	Nationwide
20 Dec 2023Device	CLASS II	Para-Pak Zn-PVA/10% Formalin-for the routine collection recalled	Meridian Bioscience	Foreign Material	Nationwide
20 Dec 2023Device	CLASS II	Cardinal Health Clean Stool Transportation System recalled	Meridian Bioscience	Packaging Defects	Nationwide
1 Feb 2023Device	CLASS II	Revogene Sars-CoV-2_IVD real-time Rt-pcr test intended recalled	Meridian Bioscience	Foreign Material	Nationwide
3 Aug 2022Device	CLASS II	Revogene, Catalog no. 610210. IVD test instrument recalled	Meridian Bioscience	Device Malfunction	Nationwide
6 Apr 2022Device	CLASS II	Revogene, For In Vitro Diagnostic use recalled by Meridian Bioscience	Meridian Bioscience	Other	Nationwide
19 May 2021Device	CLASS II	Revogene RNA recalled by Meridian Bioscience	Meridian Bioscience	Potency & Assay	Nationwide
19 May 2021Device	CLASS II	Revogene Sars-CoV recalled by Meridian Bioscience	Meridian Bioscience	Other	Nationwide
31 Mar 2021Device	CLASS II	The ImmunoCard Mycoplasma EIA detects the presence of IgM to M recalled	Meridian Bioscience	Device Malfunction	Nationwide
23 Jan 2019Device	CLASS II	Premier Cryptococcal Antigen recalled by Meridian Bioscience	Meridian Bioscience	Potency & Assay	Nationwide
25 Jan 2017Device	CLASS II	Premier Ehec and Premier Ehec Bulk recalled by Meridian Bioscience	Meridian Bioscience	Other	38 states
9 Jul 2014Device	CLASS II	illumipro-10 Incubator/Reader, Meridian Bioscience recalled	Meridian Bioscience	Temperature Abuse	17 states

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.