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Meridian Bioscience, Group B Streptococcus, Catalog Number… recallZ-0569-2026 · Meridian Bioscience Inc · initiated Oct 7, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Meridian Bioscience Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was 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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

Meridian Bioscience issued an "URGENT MEDICAL DEVICE CORRECTION" notice to its consignees beginning on 10/15/2025 via email. The notice explained the problem with the device, health hazard, and requested the following: "Required Actions: " Identify remaining inventory of Alethia C. difficile, Lot 480050U036. " Identify the Reaction Buffer bag located within the kit box. " Remove Reaction Buffer Tubes from Bag and inspect each cap for the presence of a gasket. " Segregate Reaction Buffer Tubes which have no gasket present. Record the quantity of tubes with no gasket present on the CONFIRMATION OF NOTIFICATION Form. " Discard Reaction Buffer Tubes which have no gasket present in accordance with local, state, or federal regulations. Note: Execution of the test procedure requires the use of a Reaction Buffer tube. The remaining components in this kit may continue to be utilized for patient testing so long as a new Reaction Buffer tube is available. Once the Reaction Buffer is depleted, the remaining kit components must be discarded in accordance with local regulations. " Meridian Bioscience Inc. will provide credit for the number of tests impacted. " Complete and return the CONFIRMATION OF NOTIFICATION Form to: Product Support Manager, Meridian Bioscience, Inc., 3471 River Hills Drive, Cincinnati, OH 45244; Fax: (513) 272-5432 or Email: [email protected]. Complete this form if there is no remaining inventory." For any question regarding this notification please call Meridian Bioscience Technical Services at 1-800-343-3858, or email at [email protected].

Recall details

Recall number
Z-0569-2026
Status
Open, Classified
Initiated by the company
Oct 7, 2025
Posted by the FDA
Nov 19, 2025
Recalling firm
Meridian Bioscience Inc
Quantity
109 in total
Product code
NJR
FDA submissions
K121044
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.

Product description

Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay

Code information (models, lots, serial numbers)

UDI/DI 00840733102196, Lot Numbers: 480350U020, Exp. 2026-06-12

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 97787).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page