Meridian Bioscience Inc recalls
Every recall we track for Meridian Bioscience Inc — 13 in all, from 2018–2025 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
13 recalls since 2017.
All FDA recall records for Meridian Bioscience Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 1 | 0 | 1 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 3 | 0 | 3 |
| 2022 | 0 | 2 | 1 | 0 | 3 |
| 2023 | 0 | 0 | 3 | 0 | 3 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 3 | 0 | 3 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Meridian Bioscience Inc product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Meridian Bioscience Inc recalls
9 shown- Lower riskMedical device
Meridian Bioscience Inc recalls Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Meridian Bioscience recalls Revogene C. difficile diagnostic assay (Lot 410300U195-201) due to potential false-negative results over time. Affected units may not detect infections correctly.
Meridian BioscienceDec 5, 2025 - Lower riskMedical device
Meridian Bioscience Inc recalls Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Meridian Bioscience recalls specific lots of Difficile Nucleic Acid Amplification Test Assay kits due to potential buffer leakage from missing rubber gaskets. Affected kits may have reduced buffer volume and leakage risks.
Meridian BioscienceOct 7, 2025 - Lower riskMedical device
Meridian Bioscience Inc recalls Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of
Meridian Bioscience recalls certain clean stool transportation systems due to a manufacturing defect that may cause leakage. This affects specific catalog numbers and lot numbers.
Meridian BioscienceOct 19, 2023 - Use cautionMedical device
Meridian Bioscience Inc recalls Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog
Meridian Bioscience recalls Revogene SARS-CoV-2 test kits with potential specimen leakage, risking lab exposure to SARS-CoV-2. Affected lots include 410700P019 to 410700P024 and 410700P027.
Meridian BioscienceDec 15, 2022 - Use cautionMedical device
Meridian Bioscience Inc recalls Revogene, Catalog no. 610210. IVD test instrument
Meridian Bioscience recalls Revogene IVD test instrument (Catalog 610210) due to potential minor burns from heated components if run is aborted. Affected units have specific serial numbers.
Meridian BioscienceJun 22, 2022 - Lower riskMedical device
Meridian Bioscience Inc recalls Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded
Meridian Bioscience recalls Revogene lab test kits due to potential false positives in nucleic acid testing. Affected units include all field models with specific catalog numbers.
MeridianFeb 15, 2022 - Lower riskMedical device
Meridian Bioscience Inc recalls Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase Chain Reaction (rRT-PCR)
Meridian Bioscience recalls Revogene SARS-CoV-2 test (Catalog 410700) due to reported false negative results in emergency use. All units affected.
Meridian BioscienceApr 8, 2021 - Lower riskMedical device
Meridian Bioscience Inc recalls The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in
Meridian Bioscience recalls ImmunoCard Mycoplasma EIA kits that may give false-negative results if stored incorrectly, risking missed diagnosis of Mycoplasma pneumoniae infection.
Meridian BioscienceFeb 8, 2021 - Lower riskMedical device
Meridian Bioscience Inc recalls PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Antigen enzyme immunoassay
Meridian Bioscience recalls PREMIER Cryptococcal Antigen enzyme immunoassay kits with catalog number 602096 due to potential false negative results from unstable enzyme reagents.
Meridian BioscienceDec 17, 2018
Meridian Bioscience Inc recall questions
How many recalls has Meridian Bioscience Inc had?
13 recalls from Meridian Bioscience Inc are on record with U.S. safety agencies, from 2018–2025.
What is the most recent Meridian Bioscience Inc recall?
Meridian Bioscience Inc recalls Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300, dated Dec 5, 2025. Every Meridian Bioscience Inc recall is listed on this page, newest first.
What should I do if I have a recalled Meridian Bioscience Inc product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Meridian Bioscience Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.