Meridian Bioscience, Inc.
Meridian Bioscience, Inc. holds FDA 510(k) medical device clearances, first cleared 2003, most recent 2025, with 15 FDA device recalls on record.
Top product codes for Meridian Bioscience, Inc.
FDA recalls by Meridian Bioscience, Inc.
10 most recent of 15- Z-1019-2026 — Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
- Z-0568-2026 — Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
- Z-0569-2026 — Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
- Z-0520-2024 — Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012
- Z-0519-2024 — Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312
- Z-0521-2024 — Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: CHB900312
- Z-1008-2023 — Revogene SARS-CoV-2_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700
- Z-1479-2022 — Revogene, Catalog no. 610210. IVD test instrument
- Z-0836-2022 — Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Catalog Number 130840
- Z-1541-2021 — Revogene RNA Software Upgrade Kit Revogene RNA Software Upgrade USBs Catalog Number: 610240 IVD used to install the Revogene System Software version 4.2.0, import the Revogene Instrument Control Protocol file for RNA-based assay, and install the Assay Definition File (ADF) file
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Meridian Bioscience, Inc.
- K243922 — Revogene
- K230901 — Premier HpSA Flex (619096)
- K222829 — Curian® Shiga Toxin
- K222779 — Revogene
- K220480 — Revogene
- K210976 — Curian Campy
- K192817 — Curian HpSA, Curian Analyzer
- DEN180040 — Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
- K182559 — PREMIER Platinum HpSA PLUS
- K163273 — TRU Legionella
- K160829 — illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10
- K153661 — ImmunoCard STAT! HpSA
- K152285 — illumigene Pertussis DNA Amplification Assay
- K152800 — illumigene Mycoplasma DNA Amplification Assay
- K151046 — illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10
- K133673 — ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA
- K133714 — TRU FLU
- K123423 — ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT
- K122019 — STREPTOCOCCUS APP. SEROLOGICAL REAGENTS
- K121044 — ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM
- K113190 — TRU LEGIONELLA
- K112048 — IMMUNOCARD C. DIFFICILE GDH
- K112125 — ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT
- K110620 — PREMIER C. DIFFICILE GDH
- K110012 — ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
- K100818 — ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920
- K092553 — TRU FLU, MODEL 751230
- K090700 — IMMUNOCARD STAT CAMPY, MODEL 751530
- K083464 — PREMIER CAMPY, MODEL 618096
- K071657 — TRU FLU
- K071101 — TRU RSV
- K062546 — IMMUNOCARD STAT! EHEC, MODEL 751630
- K053335 — PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480
- K041626 — IMMUNOCARD STAT! FLU A & B
- K041003 — IMMUNOCARD TOXINS A & B, MODEL 712050
- K041445 — IMMUNOCARD STAT! RSV MODEL #750630
- K032222 — IMMUNOCARDSTAT HPSA
- K023599 — IMMUNOCARD STAT! E. COLI O157 PLUS
Data sourced from openFDA. This site is unofficial and independent of the FDA.