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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 3 of 5

Device	Model / Reference	Registries	Class	Status
Para-Pak SVT	901612	FDA UDI	Class I	Active
SpinCon	972500	FDA UDI	Class I	Unknown
Coccidioides "F" Antigen for Fungal Immunodiffusion	100401	FDA UDI	Class II	Active
Para-Pak C&S/Ultra 10%/Clean	338812	FDA UDI	Class I	Active
Revogene Carba C	410500	FDA UDI	Class II	Active
Alethia™ C. difficile	480050	FDA UDI	Class I	Active
MONOSPOT Latex	776150	FDA UDI	Class II	Active
ImmunoCard STAT! EHEC	751630	FDA UDI	Class I	Active
Para-Pak SAF/C&S	300412	FDA UDI	Class I	Unknown
Para-Pak Ultra EcoFix	981312	FDA UDI	Class I	Unknown
TRU Legionella	751930	FDA UDI	Class II	Active
illumigene Mycoplasma	280550	FDA UDI	Class II	Unknown
Para-Pak SpinCon (No Funnels)	973500	FDA UDI	Class I	Active
ImmunoCard STAT! HpSA	750220	FDA UDI	Class I	Active
Para-Pak EcoFix	9014-01	FDA UDI	Class I	Active
Para-Pak 5% Formalin, Non-Buffered Formalin with HCL	901112	FDA UDI	Class I	Unknown
Para-Pak Macro-CON	970120	FDA UDI	Class I	Active
Para-Pak Zn-PVA / 10% Formalin	301012	FDA UDI	Class I	Active
illumigene Group A Streptococcus External Control Kit	279910	FDA UDI	Class II	Unknown
Premier Campy	618096	FDA UDI	Class I	Active
Para-Pak SAF	9002-01	FDA UDI	Class I	Active
Para-Pak LV-PVA	9001-01	FDA UDI	Class I	Active
Para-Pak CON-Trate	960500	FDA UDI	Class I	Active
Para-Pak SVT	9016-01	FDA UDI	Class I	Active
Para-Pak EcoFix in Biobags	991320	FDA UDI	Class I	Active
Modified Hemo-De	801600	FDA UDI	Class I	Active
Para-Pak SAF / Clean	300212	FDA UDI	Class I	Active
Alethia™ Group B Streptococcus	480350	FDA UDI	Class I	Active
Para-Pak CLEAN	900312	FDA UDI	Class I	Unknown
Para-Pak TRICHROME STAIN	400101	FDA UDI	Class I	Active
illumigene HSV 1&2	280650	FDA UDI	Class II	Unknown
Para-Pak Zn-PVA / 10% Formalin / C&S	331184	FDA UDI	Class I	Active
Para-Pak LV-PVA	900112	FDA UDI	Class I	Active
Para-Pak Ultra EcoFix/Clean	381312	FDA UDI	Class I	Unknown
Coccidioides "TP" Antigen for Fungal Immunodiffusion	103001	FDA UDI	Class II	Active
Para-Pak SAF	910212	FDA UDI	Class I	Active
Coccidioides "F" Antigen for Fungal Immunodiffusion	100405	FDA UDI	Class II	Active
Para-Pak Ultra 10% Formalin	980412	FDA UDI	Class I	Unknown
Para-Pak Zn-PVA	901012	FDA UDI	Class I	Active
Alethia Malaria External Control Kit	479970	FDA UDI	Class II	Active
Alethia™ CMV External Control Kit	479880	FDA UDI	Class II	Active
illumigene C. difficile	280050	FDA UDI	Class I	Unknown
Para-Pak Ultra SVT	981612	FDA UDI	Class I	Unknown
CALAS Pronase	140050	FDA UDI	Class II	Active
Alethia™ Mycoplasma Direct External Control Kit	479890	FDA UDI	Class II	Active
Para-Pak LV-PVA / 10% Formalin / C&S	330284	FDA UDI	Class I	Active
Para-Pak SAF / Clean	300212	FDA UDI	Class I	Active
Anti-Histoplasma Control Serum (Goat) for Immunodiffusion	100601	FDA UDI	Class II	Active
illumigene HSV 1&2 External Control Kit	279960	FDA UDI	Class II	Unknown
Histoplasma Antigen for Fungal Immunodiffusion	100201	FDA UDI	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.