Recall Register

Food, drugs, devices › Firms

Meridian Bioscience Inc

FDA recalling firm · 11 enforcement events · 15 product records · 2014–2025 · OH

Meridian Bioscience Inc has 11 FDA enforcement events on this register (15 product records) between 2014 and 2025: 11 device; the busiest year was 2022 with 3.

0% of its events are Class I; the most common class is Class II (11). 6 events are listed as ongoing; the recalling firm's address is in OH.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
5 Dec 2025Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300DeviceClass II1Ongoing
7 Oct 2025Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test AssayDeviceClass II2Ongoing
19 Oct 2023Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312DeviceClass II3Ongoing
15 Dec 2022Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700DeviceClass II1Ongoing
22 Jun 2022Revogene, Catalog no. 610210. IVD test instrumentDeviceClass II1Ongoing
15 Feb 2022Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840DeviceClass II1Ongoing
8 Apr 2021Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR) qualitative test run on the Revogene¿ instrument for the detection of SARS-CoV-2 nucleic acid from nasopharyngeal swab (NPS) specimens from individuals suspected of COVID-19DeviceClass II2Terminated
8 Feb 2021The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.DeviceClass II1Terminated
17 Dec 2018PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay (EIA) is a screening or a semi-quantitative test system for the detection of capsular polysaccharide antigens of Cryptococcus neoformans in serum and cerebrosoinal fluid (CSF).DeviceClass II1Terminated
8 Nov 2016PREMIER EHEC and PREMIER EHEC Bulk.DeviceClass II1Terminated
22 Apr 2014illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and reads endpoint reactions.DeviceClass II1Terminated

By type and class

Device11
Class II11

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

14
16
18
20
22
24
26
Enforcement events for Meridian Bioscience Inc by year initiated.

Questions and answers

How many FDA recalls has Meridian Bioscience Inc had?

11 enforcement events (15 product records) on this register, 2014–2025: 11 device.

Are any Meridian Bioscience Inc recalls ongoing?

6 events are listed as ongoing in the current openFDA export.

What class are Meridian Bioscience Inc recalls?

11 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.