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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 1 of 5

Device	Model / Reference	Registries	Class	Status
Para-Pak CLEAN	9003-01	FDA UDI	Class I	Active
Para-Pak Ultra SVT	9016-02	FDA UDI	Class I	Unknown
illumigene Mycoplasma Direct	280250	FDA UDI	Class II	Unknown
Para-Pak Zn-PVA / 10% Formalin / Clean	331084	FDA UDI	Class I	Active
ImmunoCard STAT! FLU A&B Nasopharyngeal Wash/Aspriate Kit	781130	FDA UDI	Class II	Active
MERIFLUOR EBV VCA IgG/IgM IFA	EB211	FDA UDI	Class I	Unknown
PREMIER C. difficile GDH	611096	FDA UDI	Class I	Active
illumipro-10	610172	FDA UDI	Class II	Active
Para-Pak Direct Detect	990125	FDA UDI	Class I	Active
FLU/RSV Positive Control	751110	FDA UDI	Class I	Unknown
Para-Pak Zn-PVA	9012-01	FDA UDI	Class I	Active
Para-Pak Enteric Plus	900812	FDA UDI	Class I	Active
Pak Para-C&S/Ultra 10%/Clean	338812	FDA UDI	Class I	Unknown
illumigene Pertussis	280750	FDA UDI	Class II	Unknown
Alethia™ Group A Streptococcus External Control Kit	479910	FDA UDI	Class II	Active
Meridian Viral Transport	505021	FDA UDI	Class I	Active
Revogene GBS LB	410200	FDA UDI	Class I	Active
Revogene® C. difficile	410300	FDA UDI	Class II	Unknown
Para-Pak LV-PVA / 10% Formalin / Clean	330184	FDA UDI	Class I	Unknown
illumigene Mycoplasma External Control Kit	279940	FDA UDI	Class II	Unknown
Para-Pak Enteric Plus	9008-01	FDA UDI	Class I	Active
ImmunoCard C. difficile GDH	716050	FDA UDI	Class I	Active
Mock Pie	610208	FDA UDI	Class II	Unknown
Alethia™ Group B Streptococcus External Control Kit	479900	FDA UDI	Class I	Active
Para-Pak Ultra SAF / Clean	380212	FDA UDI	Class I	Unknown
Para-Pak EcoFix	401301	FDA UDI	Class I	Active
Para-Pak ULTRA 10% Formalin	9004-03	FDA UDI	Class I	Unknown
Para-Pak LV-PVA / 10% Formalin / Clean	330184	FDA UDI	Class I	Unknown
MERIFLUOR Cryptosporidium/Giardia	250050	FDA UDI	Class II	Active
Para-Pak SAF in Tubs	990160	FDA UDI	Class I	Unknown
Para-Pak Ultra SVT	981612	FDA UDI	Class I	Unknown
Merifluor Ebv-Na	EN100	FDA UDI	Class I	Unknown
Alethia™ Pertussis External Control Kit	479930	FDA UDI	Class II	Active
RSV Positive Control	751110	FDA UDI	Class I	Active
Hemo-De	801300	FDA UDI	Class I	Active
Para-Pak CON-Trate	960050, 960200 Inner Box	FDA UDI	Class I	Unknown
PREMIER Adenoclone	696007	FDA UDI	Class I	Active
Para-Pak Ultra 10% Formalin	980412	FDA UDI	Class I	Unknown
ImmunoCard H. pylori	710030	FDA UDI	Class I	Active
Trichrome Stain	4001-01	FDA UDI	Class I	Active
MERIFLUOR EBV VCA IgM IFA	EB150	FDA UDI	Class I	Unknown
Para-Pak C&S in Biobags	990620	FDA UDI	Class I	Active
Pediatric Urea Hydrolysis Rate Calculation Application pUHR-CA	2.0	FDA UDI	Class III	Active
PREMIER Rotaclone	696004	FDA UDI	Class I	Active
ANA Screen ELISA Test Kit	4884261	FDA UDI	Class II	Active
Para-Pak Ultra SAF	980212	FDA UDI	Class I	Unknown
ImmunoCard STAT! Rotavirus	750030	FDA UDI	Class I	Active
Para-Pak C&S	9006-01	FDA UDI	Class I	Active
Alethia™ Group A Streptococcus	480150	FDA UDI	Class II	Active
Alethia™ C. difficile External Control Kit	479920	FDA UDI	Class I	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.