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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 5 of 5

Device	Model / Reference	Registries	Class	Status
Illumigene Mycoplasama Dna Amplification Assay, And Illumigene Mycoplasma External Controls Kit	K123423	FDA 510(k)	Class II	Active
Immunocard Stat Campy, Model 751530	K090700	FDA 510(k)	Class I	Active
Curian Campy	K210976	FDA 510(k)	Class I	Active
Curian® Shiga Toxin	K222829	FDA 510(k)	Class I	Active
Tru Legionella	K113190	FDA 510(k)	Class II	Active
PREMIER Platinum HpSA PLUS	K182559	FDA 510(k)	Class I	Active
Illumigene C. Difficile, Illumipro-10 And Illumigene C. Difficile External Control Kit, Models 280050, 610172, 279920	K100818	FDA 510(k)	Class I	Active
ImmunoCard STAT! HpSA	K153661	FDA 510(k)	Class I	Active
Immunocard Stat! E. Coli O157 Plus	K023599	FDA 510(k)	Class I	Active
TRU Legionella	K163273	FDA 510(k)	Class II	Active
Illumigene Group B Streptococcus Carrot Broth Claim	K121044	FDA 510(k)	Class I	Active
Curian HpSA, Curian Analyzer	K192817	FDA 510(k)	Class I	Active
Tru Flu	K071657	FDA 510(k)	Class II	Active
Illumigene Group B Streptococcus , External Control Kit	K112125	FDA 510(k)	Class I	Active
Premier Platinum Hpsa Plus, Models 601396, 601480	K053335	FDA 510(k)	Class I	Active
Immunocard Toxins A & B, Model 712050	K041003	FDA 510(k)	Class I	Active
Tru Flu, Model 751230	K092553	FDA 510(k)	Class II	Active
Premier HpSA Flex (619096)	K230901	FDA 510(k)	Class I	Active
illumigene Pertussis DNA Amplification Assay	K152285	FDA 510(k)	Class II	Active
Tru Flu	K133714	FDA 510(k)	Class II	Active
Tru Rsv	K071101	FDA 510(k)	Class I	Active
Immunocardstat Hpsa	K032222	FDA 510(k)	Class I	Active
Immunocard Stat! Ehec, Model 751630	K062546	FDA 510(k)	Class I	Active
Premier C. Difficile Gdh	K110620	FDA 510(k)	Class I	Active
illumigene Mycoplasma DNA Amplification Assay	K152800	FDA 510(k)	Class II	Active
Immunocard Stat! Flu A & B	K041626	FDA 510(k)	Class II	Active
Streptococcus App. Serological Reagents	K122019	FDA 510(k)	Class I	Active
Immunocard Stat! Rsv Model #750630	K041445	FDA 510(k)	Class I	Active
Illumigene C. Difficile, And Illumipro-10	K110012	FDA 510(k)	Class I	Active
Alethia	610189	EUDAMEDFDA UDI	Class A	Active
Para-Pak® C&S	900612	EUDAMEDFDA UDI	Class A	Active
Para-Pak® SVT	901612	EUDAMEDFDA UDI	Class A	Active
Curian Analyzer	610190	EUDAMEDFDA UDI	Class A	Active
Para-Pak® 10% Formalin	900412	EUDAMEDFDA UDI	Class A	Active
Breath Tek Ubtfor H. Pylori Kit	P100025	FDA PMA	Class III	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.