--- title: "Meridian Bioscience Inc Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Meridian Bioscience Inc recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/meridian-bioscience-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Meridian Bioscience Inc recall records **9** reported ongoing 9 records in this archive. Latest source date Dec 5, 2025. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Dec 5, 2025 FDA device enforcement ### [Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300](https://isitonrecall.com/recall/fda-device-z-1019-2026-revogene-c-difficile-in-vitro-diagnostic-assay-intended-for-use-with-the-revogene-instrument-catalog/) The affected lots show a decline in performance over time, which may lead to false-negative results. Class II Reported ongoing Distribution: US Nationwide distribution and the OUS country of Italy. [Official source for Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, C...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1019-2026%22) Oct 7, 2025 FDA device enforcement ### [Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay](https://isitonrecall.com/recall/fda-device-z-0568-2026-meridian-bioscience-alethia-c-difficile-catalog-number-480050-nucleic-acid-amplification-test-assay/) The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume. Class II Reported ongoing Distribution: US Distribution to states of: AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN, TX and WA; and OUS (foreign) countries of: Canada, Italy, and Panama. [Official source for Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0568-2026%22) Oct 7, 2025 FDA device enforcement ### [Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay](https://isitonrecall.com/recall/fda-device-z-0569-2026-meridian-bioscience-group-b-streptococcus-catalog-number-480050-nucleic-acid-amplification-test-assa/) The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume. Class II Reported ongoing Distribution: US Distribution to states of: AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN, TX and WA; and OUS (foreign) countries of: Canada, Italy, and Panama. [Official source for Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Tes...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0569-2026%22) Oct 19, 2023 FDA device enforcement ### [Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Number: 900312](https://isitonrecall.com/recall/fda-device-z-0519-2024-para-pak-clean-vial-for-the-collection-transportation-preservation-and-examination-of-stool-specimen/) 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. Class II Reported ongoing Distribution: Nationwide Foreign: Italy [Official source for Para-Pak Clean Vial-For the collection, transportation, preservation, and examination of stool sp...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0519-2024%22) Oct 19, 2023 FDA device enforcement ### [Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examination of stool specimens for intestinal parasites Catalog Number: 301012](https://isitonrecall.com/recall/fda-device-z-0520-2024-para-pak-zn-pva-10-formalin-for-the-routine-collection-transportation-preservation-and-examination-o/) 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. Class II Reported ongoing Distribution: Nationwide Foreign: Italy [Official source for Para-Pak Zn-PVA/10% Formalin-for the routine collection, transportation, preservation, and examin...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0520-2024%22) Oct 19, 2023 FDA device enforcement ### [Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservation, and examination of stool specimens containing intestinal parasites Catalog Nu...](https://isitonrecall.com/recall/fda-device-z-0521-2024-cardinal-health-clean-stool-transportation-system-for-the-collection-transportation-preservation-and/) Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage. Class II Reported ongoing Distribution: Nationwide Foreign: Italy [Official source for Cardinal Health Clean Stool Transportation System-For the collection, transportation, preservatio...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0521-2024%22) Dec 15, 2022 FDA device enforcement ### [Revogene SARS-CoV-2\_IVD real-time RT-PCR test intended for the qualitative detection of RNA from SARSCoV-2 Catalog Number: 410700](https://isitonrecall.com/recall/fda-device-z-1008-2023-revogene-sars-cov-2-ivd-real-time-rt-pcr-test-intended-for-the-qualitative-detection-of-rna-from-sar/) 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 Class II Reported ongoing Distribution: US Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN, NC, NY, OR, TX. [Official source for Revogene SARS-CoV-2\_IVD real-time RT-PCR test intended for the qualitative detection of RNA from ...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1008-2023%22) Jun 22, 2022 FDA device enforcement ### [Revogene, Catalog no. 610210. IVD test instrument](https://isitonrecall.com/recall/fda-device-z-1479-2022-revogene-catalog-no-610210-ivd-test-instrument/) 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 m... Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide and the countries of Australia, Chile, Italy, Qatar, and Switzerland. [Official source for Revogene, Catalog no. 610210. IVD test instrument](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-1479-2022%22) Feb 15, 2022 FDA device enforcement ### [Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories. Meridian branded Revogene: Catalog Number 610210 GenePOC branded Revogene: Cat...](https://isitonrecall.com/recall/fda-device-z-0836-2022-revogene-for-in-vitro-diagnostic-use-in-performing-nucleic-acid-testing-in-clinical-laboratories-mer/) 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. Class II Reported ongoing Distribution: Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NV, ... [Official source for Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories...](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0836-2022%22) ## Reasons in these listed records - The affected lots show a decline in performance over time, which may lead to false-negative results. - The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume. - 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. - Due to a manufacturing defect, certain Para-Pak vials may be at risk for leakage. These examples come from this result page and are not a ranking of every recall reason. ## Checking Meridian Bioscience Inc ### Is there a recall on meridian bioscience inc right now? This archive contains 9 records, including 9 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Meridian Bioscience Inc](https://isitonrecall.com/check/?q=Meridian%20Bioscience%20Inc) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)