VERIGENE Clostridium difficile Nucleic Acid Test, REF… recallZ-2024-2023 · Luminex Corporation · initiated Jun 5, 2023
Open, Classified
Is my device affected?
- 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.
- If yours is listed, follow the instructions from Luminex Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- 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
It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result due to hydrophobic characteristics in specific FLOQSwab lots.
FDA root cause category: Other
What the company is doing
Luminex issued an Urgent Field Safety Notice - Medical Device Recall notice on 06/05/2023 by email. The notice explained the problem with the stool prep kit, the risk, and requested isolation/quarantine, cease of use, and disposal of the affected products.
Recall details
- Recall number
- Z-2024-2023
- Status
- Open, Classified
- Initiated by the company
- Jun 5, 2023
- Posted by the FDA
- Jun 28, 2023
- Recalling firm
- Luminex Corporation
- Quantity
- 114 units
- Product code
- OZN
- FDA submissions
- K123197
- Distribution
- Worldwide and US Nationwide Distribution
Product description
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Code information (models, lots, serial numbers)
UDI/DI , Lot Numbers: 071222022D, 100622022D
Other devices under the same FDA submission
1 device cleared under K123197 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Clostridium difficile (CDF) Stool Sample Preparation Kit 30-002-022Luminex Corporation · C. Difficile toxin gene amplification assay1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 92451).
- Z-2023-2023 · Open, ClassifiedVerigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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