Reported Jul 5, 2023 · Ongoing
VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
Luminex Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Luminex Corporation · 4088 Commercial Ave · Northbrook, IL · 60062-1829
Is this the product you have?
- VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
- Lot codes and dates
- UDI/DI
- Lot Numbers
071222022D100622022D
- Amount recalled
- 114 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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