Meridian Bioscience Inc Revogene C. difficile, in vitro diagnostic assay intended recall: The affected lots show a decline in performance over time
The affected lots show a decline in performance over time, which may lead to false-negative results.
The hazard: Device safety concern
A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
What the notice says: The affected lots show a decline in performance over time, which may lead to false-negative results.
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-1019-2026
- Published
- January 14, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Meridian Bioscience Inc
- Product type
- Medical devices
- Units affected
- 211 units
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- UDI-DI: 00840733102349; Lot Numbers: 410300U195, 410300U196, 410300U197, 410300U201
- UPC codes
- 00840733102349
Products covered by this recall
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Check your product
The notice names 6 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.
- 00840733102349
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- 410300U195
- 410300U196
- 410300U197
- 410300U201 — 211 units
Model or item number
On the rating label, the box or the instruction sheet.
- 410300 — UDI-DI
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 — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- Ask the supplier or clinic that provided it what the remedy is in your case.
- If you are a facility, quarantine affected stock and log the correction.
- Report device problems to the FDA through MedWatch.
Claiming on a recalled device
Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.
- Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
- Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
- If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
- Log the date, the name and the reference number of every call. Device recalls can run for months.
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 affected lots show a decline in performance over time, which may lead to false-negative results. The affected lots show a decline in performance over time, which may lead to false-negative results.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 00840733102349; lot code 410300U195, 410300U196, 410300U197; model number 410300 — UDI-DI. 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?
Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
Where was the recalled product sold?
It was distributed nationwide.
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