Meridian Bioscience Inc
FDA Regulatory Profile
Meridian Bioscience Inc appears in FDA public data with 15 recalls, 38 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1019-2026, Class II) was initiated on December 5, 2025. Its most recent 510(k) clearance was granted on March 20, 2025.
Summary
- Total Recalls
- 15
- 510(k) Clearances
- 38
- Inspections
- 3
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1019-2026 | Class II | Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Cata | December 5, 2025 |
| Z-0569-2026 | Class II | Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test A | October 7, 2025 |
| Z-0568-2026 | Class II | Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test A | October 7, 2025 |
| Z-0520-2024 | Class II | Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examinati | October 19, 2023 |
| Z-0521-2024 | Class II | Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, | October 19, 2023 |
| Z-0519-2024 | Class II | Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool speci | October 19, 2023 |
| Z-1008-2023 | Class II | Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SA | December 15, 2022 |
| Z-1479-2022 | Class II | Revogene, Catalog no. 610210. IVD test instrument | June 22, 2022 |
| Z-0836-2022 | Class II | Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. | February 15, 2022 |
| Z-1541-2021 | Class II | Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD | April 8, 2021 |
| Z-1540-2021 | Class II | Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase C | April 8, 2021 |
| Z-1299-2021 | Class II | The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: | February 8, 2021 |
| Z-0732-2019 | Class II | PREMIER Cryptococcal Antigen, Catalog Number 602096 Product Usage: The PREMIER Cryptococcal Ant | December 17, 2018 |
| Z-1033-2017 | Class II | PREMIER EHEC and PREMIER EHEC Bulk. | November 8, 2016 |
| Z-1941-2014 | Class II | illumipro-10 Incubator/Reader, Meridian Bioscience, Inc. The illumipro-10 incubator/reader is des | April 22, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243922 | Revogene | March 20, 2025 |
| K230901 | Premier HpSA Flex (619096) | July 3, 2023 |
| K222829 | Curian® Shiga Toxin | April 17, 2023 |
| K222779 | Revogene | January 26, 2023 |
| K220480 | Revogene | July 11, 2022 |
| K210976 | Curian Campy | December 23, 2021 |
| K192817 | Curian HpSA, Curian Analyzer | March 13, 2020 |
| DEN180040 | Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit | November 30, 2018 |
| K182559 | PREMIER Platinum HpSA PLUS | November 5, 2018 |
| K163273 | TRU Legionella | February 21, 2017 |
| K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls | June 13, 2016 |
| K153661 | ImmunoCard STAT! HpSA | March 14, 2016 |
| K152285 | illumigene Pertussis DNA Amplification Assay | November 10, 2015 |
| K152800 | illumigene Mycoplasma DNA Amplification Assay | October 23, 2015 |
| K151046 | illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10 | July 17, 2015 |
| K133673 | ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 | March 25, 2014 |
| K133714 | TRU FLU | January 3, 2014 |
| K123423 | ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT | June 5, 2013 |
| K122019 | STREPTOCOCCUS APP. SEROLOGICAL REAGENTS | September 13, 2012 |
| K121044 | ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM | May 1, 2012 |