Use cautionMedical device recall · FDA · Published December 15, 2022
Meridian Bioscience Revogene SARS-CoV-2 Test Recall: Specimen Leakage Risk
Meridian Bioscience recalls Revogene SARS-CoV-2 test kits with potential specimen leakage, risking lab exposure to SARS-CoV-2. Affected lots include 410700P019 to 410700P024 and 410700P027.
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
Take action
Contact the company
📍Recalling firmMeridian Bioscience Inc3471 River Hills Dr · Cincinnati, OH 45244-3023
“Meridian Bioscience Revogene SARS-CoV-2 Test Recall: Specimen Leakage Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59111-meridian-bioscience-revogene-sars-cov-2-test-recall-specimen-leakage. Based on FDA recall #Z-1008-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1008-2023%22&limit=1).
The FDA announced on Dec. 15, 2022, that Meridian Bioscience Inc is recalling Revogene SARS-CoV-2_IVD real-time RT-PCR tests due to leakage risks. The agency said the hazard involves potential exposure to aerosolized specimen containing SARS-CoV-2.
How to tell if you have it
Brand: Meridian Bioscience
Product: Revogene SARS-CoV-2_IVD real-time RT-PCR test
Catalog Number: 410700
Lot Numbers: 410700P019, 410700P020, 410700P021, 410700P022, 410700P023, 410700P024, 410700P027
Units affected: 92 kits
The hazard
According to the FDA, leakage of the original specimen from the plastic microfluidic cartridge (PIE) creates a possibility that laboratory personnel may be exposed to aerosolized specimen containing SARS-CoV-2.
Context
GovInfoNow's records show Meridian Bioscience Inc has 8 other recalls on record since Dec. 17, 2018. Other recent recalls of similar products include the Revogene C. difficile Test Recall (Dec. 5, 2025), the Group B Strep Test Kit Recall (Oct. 7, 2025), and the Para-Pak Zn-PVA/10% Formalin Recall (Oct. 19, 2023).
How to tell if you have this one
Check the lot number on the test kit packaging. Affected lots are 410700P019 through 410700P024 and 410700P027.
Brand
Meridian Bioscience
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Lot Number
Look for the lot number on the test kit packaging to determine if it is affected (410700P019 to 410700P024 or 410700P027).
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 12 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AZ, CA, IN, KS, KY, LA, MI, MN, NC, NY, OR, TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, New York, North Carolina, Oregon, Texas.
Recall timeline
FDA published this recall 48 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1008-2023 (December 15, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1008-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.