Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Summary
The FDA issued a Class II for Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid by Meridian Bioscience Inc. Reason: The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume..
Details
Source
Device Recall
External ID
Z-0568-2026
Action Date
2025-11-26
Status
Ongoing
Category
device
Product Description
Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay
Lot/Code Info: UDI/DI 00840733102172, Lot Numbers: 480050U036, Exp. 2026-08-01; 480050U037, Exp. 2026-09-04
Quantity Affected: 109 in total
Reason for 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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-10-07
Company
Cincinnati, OH
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 222 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Meridian Bioscience Inc has 14 FDA actions in our database, including 9 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Meridian Bioscience Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Meridian Bioscience Inc have FDA actions?
Meridian Bioscience Inc has 14 FDA actions in our database, including 9 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0568-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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