Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of SD BiosensorLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Meridian Bioscience with 37 510(k) clearances, 15 device recalls, 1 drug application and 1 warning letter. The most recent is a warning letter dated Dec 22, 2025: Warning letter: Method validation, CAPA, MDR reporting.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 22, 2025 | Warning letter: Method validation, CAPA, MDR reportingCDRH | Warning letters |
| Dec 5, 2025 | Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300Class II · The affected lots show a decline in performance over time, which may lead to false-negative results. | Device recalls |
| Oct 7, 2025 | Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test AssayClass II · The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and re | Device recalls |
| Oct 7, 2025 | Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test AssayClass II · The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and re | Device recalls |
| Mar 20, 2025 | RevogeneK243922 · OOI | 510(k) clearances |
| Oct 19, 2023 | Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens contaClass II · Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage. | Device recalls |
| Oct 19, 2023 | Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parClass II · Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental e | Device recalls |
| Oct 19, 2023 | Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites CaClass II · Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental e | Device recalls |
| Jul 3, 2023 | Premier HpSA Flex (619096)K230901 · LYR | 510(k) clearances |
| Apr 17, 2023 | Curian® Shiga ToxinK222829 · GMZ | 510(k) clearances |
| Jan 26, 2023 | RevogeneK222779 · OOI | 510(k) clearances |
| Dec 15, 2022 | Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700Class II · Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel ma | Device recalls |
| Jul 11, 2022 | RevogeneK220480 · OOI | 510(k) clearances |
| Jun 22, 2022 | Revogene, Catalog no. 610210. IVD test instrumentClass II · When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the co | Device recalls |
| Dec 23, 2021 | Curian CampyK210976 · LQP | 510(k) clearances |
| Mar 13, 2020 | Curian HpSA, Curian AnalyzerK192817 · LYR | 510(k) clearances |
| Nov 30, 2018 | Alethia CMV DNA Amplification Assay, Alethia CMV External Control KitDEN180040 · QDZ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
