Meridian Bioscience Recalls Difficile Nucleic Acid Test Kit Due to Buffer Leakage Risk
Meridian Bioscience recalls specific lots of Difficile Nucleic Acid Amplification Test Assay kits due to potential buffer leakage from missing rubber gaskets. Affected kits may have reduced buffer volume and leakage risks.
Lower-risk recall
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
Contact the company
What happened, in plain English
Meridian Bioscience is recalling certain lots of Difficile Nucleic Acid Amplification Test Assay kits because the cap on the reaction buffer tube might be missing a black rubber gasket. This could cause leakage and reduce buffer volume, potentially affecting test accuracy. Read more at govinfonow.com/recall/51096-meridian-bioscience-recalls-difficile-nucleic-acid-test-kit-due-to.
Source Summary by GovInfoNow · govinfonow.com/recall/51096-meridian-bioscience-recalls-difficile-nucleic-acid-test-kit-due-to · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0568-2026
Cite this page
“Meridian Bioscience Recalls Difficile Nucleic Acid Test Kit Due to Buffer Leakage Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51096-meridian-bioscience-recalls-difficile-nucleic-acid-test-kit-due-to. Based on FDA recall #Z-0568-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0568-2026%22&limit=1).
Why it’s dangerous
The cap on the reaction buffer tube may not have the black rubber gasket that seals it properly. This can lead to leakage of the buffer solution and reduced buffer volume, which might affect the accuracy of the test results.
Who’s affected
Users of the Difficile Nucleic Acid Amplification Test Assay kits with specific catalog numbers and lot numbers are affected. Laboratory personnel and healthcare providers using these kits are most at risk.
How to tell if you have this one
Check for the catalog number 480050 and lot numbers 480050U036 (expiring August 2026) or 480050U037 (expiring September 2026) on the kit packaging.
- Brand
Meridian Bioscience- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
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.
| Recall number | Product, codes & lots |
|---|---|
| Z-0568-2026 | Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay; UDI/DI 00840733102172, Lot Numbers: 480050U036, Exp. 2026-08-01; 480050U037, Exp. 2026-09-04 |
| Z-0569-2026 | Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay; UDI/DI 00840733102196, Lot Numbers: 480350U020, Exp. 2026-06-12 |
What to do — step by step
Check Kit Details
Look for the catalog number 480050 and lot numbers 480050U036 or 480050U037 on the kit packaging.
Where it went and when
Where it was distributed
Distributed in 14 states, and outside the U.S.
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alabama, Colorado, Florida, Georgia, Illinois, Maine, Maryland, Montana, New Hampshire, New Jersey, Ohio, Tennessee, Texas, Washington.
Recall timeline
FDA published this recall 50 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0568-2026 (October 7, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0568-2026 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.