Reported Jul 13, 2022 · Ongoing
Verigene CDF Nucleic Acid Test, Part No. 30-002-22
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 CDF Nucleic Acid Test, Part No. 30-002-22
- Lot codes and dates
4 of 4 products
Products covered by this recall # Barcodes Product as published 1 00840487101735UDI 00840487101735 Luminex Lot Number 042021022D, FLOQ Swab Lot Numbers: 2100856, 2032870 2 Luminex Lot Number 071321022F, FLOQ Swab Lot Numbers: 2100856, 2107946 3 Luminex Lot Number 100421022A, FLOQ Swab Lot Numbers: 2110850 4 Luminex Lot Number 110221022E, FLOQ Swab Lot Numbers: 2107946. - Amount recalled
- 296 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
There is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.
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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