Class II U.S. Food and Drug Administration

Meridian Bioscience, alethia c. Difficile recall: The cap on the reaction buffer tube may be missing the black rubber gasket

Recall published 11 months ago

The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0568-2026
Published
November 26, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Meridian Bioscience Inc
Product type
Medical devices
Units affected
109 in total
Distribution
Alabama, Colorado, Florida, Georgia, Illinois, Maryland, Maine, Montana, New Hampshire, New Jersey, Ohio, Tennessee, Texas, Washington
Made in
United States
Lot / code info
UDI/DI 00840733102172, Lot Numbers: 480050U036, Exp. 2026-08-01; 480050U037, Exp. 2026-09-04
UPC codes
00840733102172

Products covered by this recall

Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay

Check your product

The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00840733102172

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 480050U036
  • Exp. 2026-08-01

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 2026-08-01

Model or item number

On the rating label, the box or the instruction sheet.

  • 480050

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Meridian Bioscience Inc — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Meridian Bioscience Inc — 3471 River Hills Dr, Cincinnati, OH, 45244-3023

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Meridian Bioscience Inc medical devices recalled?

The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume. The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00840733102172; lot code 480050U036, Exp. 2026-08-01; best-by date 2026-08-01; model number 480050. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Which states were affected?

The notice lists Alabama, Colorado, Florida, Georgia, Illinois, Maryland, Maine, Montana, New Hampshire, New Jersey, Ohio, Tennessee and others.

Related recalls