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.
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
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.
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.
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.
Check for the catalog number 480050 and lot numbers 480050U036 (expiring August 2026) or 480050U037 (expiring September 2026) on the kit packaging.
Look for the catalog number 480050 and lot numbers 480050U036 or 480050U037 on the kit packaging.
Meridian Bioscience recalls specific lots of Difficile Nucleic Acid Amplification Test Assay kits with catalog number 480050 and lot numbers 480050U036 or 480050U037.
The cap on the reaction buffer tube may be missing the black rubber gasket, which can cause leakage and reduce buffer volume.
The recall record does not specify a remedy, so check the kit details to see if it is affected and contact Meridian Bioscience for further instructions.
We’ve drafted a message you can send Meridian Bioscience to request your refund or repair — edit it as you like.
Subject: Recall Z-0568-2026 — Meridian Bioscience Meridian Bioscience Hello, I own a Meridian Bioscience that is covered by recall Z-0568-2026 from Meridian Bioscience. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.