United StatesMeridian Bioscience alethia C. difficile and Group B Streptococcus nucleic acid amplification test assays, Catalog Number 480050 (UDI/DI 00840733102172 and 00840733102196; Lots 480050U036 exp. 2026-08-01, 480050U037 exp. 2026-09-04, 480350U020 exp. 2026-06-12) are being recalled. The recall was issued because the cap on the reaction buffer tube may be missing the black rubber gasket, potentially causing leakage and reduced buffer volume; 109 units were distributed in the US (AL, CO, FL, GA, IL, MD, ME, MT, NH, NJ, OH, TN, TX, WA) and to Canada, Italy, and Panama.
What's being recalled
Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Recalling firm: Meridian Bioscience Inc, Cincinnati, OH, United States.
How to identify it
UDI/DI 00840733102172, Lot Numbers: 480050U036, Exp. 2026-08-01; 480050U037, Exp. 2026-09-04 UDI/DI 00840733102196, Lot Numbers: 480350U020, Exp. 2026-06-12
The hazard
The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
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.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)