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MERIDIAN BIOSCIENCE, INC.

United States·US-MF-000044096

Last updated September 17, 2026

Information

Country: United States
Address: 3471, River Hills Drive, Cincinnati (OHIO), United States
Website: www.meridianbioscience.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 513.673.8109
PRRC Contact: Susan Bogar
EUDAMED SRN: US-MF-000044096
FDA FEI Number: 1524213
DUNS Number: —

Catalogue (235)

Page 4 of 5

Device	Model / Reference	Registries	Class	Status
Para-Pak Zn-PVA/Ultra 10% Formalin	381012	FDA UDI	Class I	Unknown
Alethia Malaria PLUS	481125	FDA UDI	Class II	Unknown
Anti-Coccidioides "F" Control Serum for Fungal Immunodiffusion	100801	FDA UDI	Class II	Active
Para-Pak Zn-PVA / 10% Formalin / C&S	331184	FDA UDI	Class I	Active
Alethia™ Mycoplasma Direct	480250	FDA UDI	Class II	Active
Curian Shiga Toxin	760630	FDA UDI	Class I	Active
Trichrome Blue Stain	400501	FDA UDI	Class I	Active
ImmunoCard Toxins A & B	712050	FDA UDI	Class I	Active
ImmunoCard Mycoplasma	709030	FDA UDI	Class I	Active
Para-Pak SAF / Clean / C&S	330384	FDA UDI	Class I	Active
BreathTek UBT for H. pylori	01	FDA UDI	Class III	Active
Para-Pak SAF (Genova Diagnostics)	9002-08	FDA UDI	Class I	Unknown
illumigene C. difficile External Control Kit	279920	FDA UDI	Class I	Unknown
ImmunoCard STAT! CAMPY	751530	FDA UDI	Class I	Active
Para-Pak EcoFix / C&S / Clean	331312	FDA UDI	Class I	Active
illumigene Group B Streptococcus	280350	FDA UDI	Class I	Unknown
Revogene® Strep A	410400	FDA UDI	Class II	Unknown
Para-Pak ULTRA SAF Fixative / Clean Vial	380212	FDA UDI	Class I	Active
Para-Pak Modified (Cu) PVA/Formalin	300812	FDA UDI	Class I	Active
Trichrome Stain	400112	FDA UDI	Class I	Active
Para-Pak Zn-PVA / 10% Formalin / Clean	331084	FDA UDI	Class I	Active
Cryptococcal Antigen Latex Agglutination System (CALAS)	140100	FDA UDI	Class II	Active
Para-Pak 10% Formalin Fixative	900412	FDA UDI	Class I	Active
CON-Trate Funnels & Reagent A	960400	FDA UDI	Class I	Active
Para-Pak Ultra EcoFix/Clean	381312	FDA UDI	Class I	Unknown
Curian HpSA	760130	FDA UDI	Class I	Active
MERIFLUOR VZV (Vericella-Zoster Virus)	500113	FDA UDI	Class II	Active
Revogene Strep A	410400	FDA UDI	Class II	Active
Revogene® Carba C	410500	FDA UDI	Class II	Active
Alethia™ Pertussis	480750	FDA UDI	Class II	Active
Para-Pak Zn-PVA / 10% Formalin	301012	FDA UDI	Class I	Active
Fungal Immunodiffusion Plates - 1 Series	101012	FDA UDI	Class I	Active
Para-Pak Ultra EcoFix / C&S / Clean	331612	FDA UDI	Class I	Unknown
Para-Pak Ultra EcoFix	9014-03	FDA UDI	Class I	Unknown
Para-Pak EcoFix / Clean	301312	FDA UDI	Class I	Active
Para-Pak Modified (Cu) PVA	9005	FDA UDI	Class I	Active
Para-Pak LV-PVA / Ultra 10% Formalin	380112	FDA UDI	Class I	Unknown
Para-Pak LV-PVA / Ultra 10% Formalin	380112	FDA UDI	Class I	Unknown
Para-Pak Ultra SAF	9002-03	FDA UDI	Class I	Active
Para-Pak SAF / Clean / C&S	330384	FDA UDI	Class I	Active
Para-Pak CON-Trate	960050	FDA UDI	Class I	Unknown
MERIFLUOR Chlamydia	500111	FDA UDI	Class I	Active
SpinCon	972200	FDA UDI	Class I	Unknown
Revogene®	610210	EUDAMEDFDA UDI	Class A	Active
Premier Campy, Model 618096	K083464	FDA 510(k)	Class I	Active
Immunocard C. Difficile Gdh	K112048	FDA 510(k)	Class I	Active
illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10	K160829	FDA 510(k)	Class II	Active
Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit	DEN180040	FDA 510(k)	Class II	Active
illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10	K151046	FDA 510(k)	Class II	Active
Illumigene Pertusis Dna Amplification Assay, Illumigene Pertussis External Control Kit, Illumipro-10 Automated Isotherma	K133673	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

Meridian Bioscience Europe S.r.l. IT

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (22)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Dec 5, 2025	Z-1019-2026	—	open, classified	The affected lots show a decline in performance over time, which may lead to false-negative results.
Oct 7, 2025	Z-0569-2026	—	open, classified	The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
Oct 7, 2025	Z-0568-2026	—	open, classified	The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
Oct 19, 2023	Z-0521-2024	—	open, classified	Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage.
Oct 19, 2023	Z-0520-2024	—	open, classified	Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated with direct contact with the patient specimen.
Oct 19, 2023	Z-0519-2024	—	open, classified	Plastic vials contain a manufacturing defect may cause an increased risk of leakage and presents a risk of incidental exposure to biological hazards associated with direct contact with the patient specimen.
Dec 15, 2022	Z-1008-2023	—	open, classified	Leakage of the original specimen from the plastic microfluidic cartridge (PIE), possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2
Jun 22, 2022	Z-1479-2022	—	open, classified	When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated instrument components. Incidental contact with heated instrument components may result in an injury such as minor burns.
Feb 15, 2022	Z-0836-2022	—	open, classified	The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results.
Apr 8, 2021	Z-1540-2021	—	terminated	Emergency Use Application (EUA) application withdrawn as false negative results reported
Apr 8, 2021	Z-1541-2021	—	terminated	Emergency Use Application (EUA) application withdrawn as false negative results reported
Feb 8, 2021	Z-1299-2021	—	terminated	Use of the kits after incorrect storage could lead to a potential false-negative or invalid result. In the event of a false-negative, the incorrect assumption would be made as to the cause of patient symptoms. The appropriate treatment may not be administered, and symptoms may progress. Additional evaluations will be completed and documented within the associated Health Hazard Evaluation.
Dec 17, 2018	Z-0732-2019	—	terminated	An enzyme reagent included in the kit is not maintaining stability through claimed product expiration, resulting in the potential for false negative results when tested with patient specimens and the positive control.
Nov 8, 2016	Z-1033-2017	—	terminated	Internal testing has demonstrated that the indicated kit lots produce false positive results when tested with some broth specimens.
Apr 22, 2014	Z-1941-2014	—	terminated	Illumipro-10 instruments may have Block B chambers operating at an incorrect temperature as a result of incorrect temperature calibration.
Oct 10, 2011	Z-0203-2012	—	terminated	Internal testing has shown that the indicated kits produce false negative results when tested with some direct stool specimens. These false negative reactions are not observed for all devices tested, however, the rate of occurrence will likely impact clinical sensitivity as defined by product registration and associated instructions for use.
Jun 2, 2006	Z-1203-06	—	terminated	The product may produce non-specific reactions with negative specimens and/or the negative control reagent. These non-specific interactions may result in increased invalid test rates and/or positivity rates.
Sep 23, 2003	Z-0062-04	—	terminated	The kits were packaged with incorrect dispensing pipettes.
Jun 18, 2003	Z-1127-03	—	terminated	The Low Positive Standard kit component is losing potency that may result in false positive test results.
Dec 26, 2002	Z-0465-03	—	terminated	Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.
Dec 26, 2002	Z-0463-03	—	terminated	Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.
Dec 26, 2002	Z-0464-03	—	terminated	Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.