Reported Jul 5, 2023 · Ongoing
Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
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 Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023
- Lot codes and dates
- UDI/DI 00840487101568
- Lot Numbers
071322023D071822023B071822023C071922023E072022023D072622023D082422023G083022023E083122023E090622023A090822023D091322023D091422023D091422023E092022023E092122023D092722023D092822023D100422023D100722023E101422023E101822023D101822023E101922023D102022023D121322023D122722023C122722023D010323023D011323023G021323023A021323023B021523023D022123023E022323023D030123023F030223023D030223023E030623023A030823023D031623023D
- Amount recalled
- 3987 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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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