Quick Facts at a Glance
- Recall Date
- December 5, 2025
- Hazard Level
- HIGH
- Brand
- Meridian Bioscience
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Meridian Bioscience
- Product type
- Diagnostic Assay
- Model numbers
- UDI-DI: 00840733102349, Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 5, 2025
Reported by FDA DEVICE
January 14, 2026
RecallRadar source check
January 21, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The affected lots show a decline in performance over time, which may lead to false-negative results.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Meridian Bioscience Inc or your healthcare provider for instructions. Notification method: Letter
About This Product
The Revogene C. difficile assay is used to diagnose C. difficile infections, which can lead to severe gastrointestinal issues. Healthcare providers rely on accurate test results for effective treatment.
Why This Is Dangerous
The decline in performance over time may prevent the assay from detecting the presence of C. difficile, resulting in false-negative results. This could lead to misdiagnosis and lack of essential treatment for patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face health risks due to potential misdiagnosis. Delayed treatment for C. difficile infections can lead to serious health complications.
Practical Guidance
How to identify if yours is affected
- Locate the catalog number 410300 on the product packaging.
- If your product matches these details, it is affected by the recall.
Where to find product info
The catalog and lot numbers are typically found on the product packaging or on the label attached to the assay.
What timeline to expect
Expect a refund processing timeline of approximately 4-6 weeks after returning the product.
If the manufacturer is unresponsive
- Document your communications with the company.
- Reach out again via phone or email.
- Consider filing a complaint with the FDA if no response is received.
How to prevent similar issues
- When purchasing medical devices, verify the manufacturer's reputation and recall history.
- Always check for recent recalls before using diagnostic devices.
- Consult healthcare professionals for alternative testing options if necessary.
Documentation advice
Keep records of your product details, receipts, and any correspondence with the manufacturer regarding the recall.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recalled product is the Revogene C. difficile in vitro diagnostic assay with Catalog Number 410300. It was distributed nationwide in the US and in Italy. The affected lot numbers are 410300U195, 410300U196, 410300U197, and 410300U201.
Key Facts
- False-negative risk due to performance decline
- Nationwide distribution in the US and Italy
- Stop using the device immediately
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
