Reported Jul 13, 2022 · Ongoing
VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
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, Part No. 30-002-23
- Lot codes and dates
54 of 54 products
Products covered by this recall # Barcodes Product as published 1 00840487101568UDI 00840487101568 Luminex Lot Number 030121023A, FLOQSwab Lot Number: 2100856 2 Luminex Lot Number 030221023D, FLOQSwab Lot Number: 2100856 3 Luminex Lot Number 030221023E, FLOQSwab Lot Number: 2100856 4 Luminex Lot Number 030221023F, FLOQSwab Lot Number: 2100856 5 Luminex Lot Number 030821023A, FLOQSwab Lot Number: 2100856 6 Luminex Lot Number 030921023D, FLOQSwab Lot Number: 2100856 7 Luminex Lot Number 031021023E, FLOQSwab Lot Number: 2100856 8 Luminex Lot Number 031621023D, FLOQSwab Lot Number: 2100856 9 Luminex Lot Number 031721023D, FLOQSwab Lot Number: 2100856 10 Luminex Lot Number 032221023A, FLOQSwab Lot Number: 2032870 11 Luminex Lot Number 032421023E, FLOQSwab Lot Number: 2032870 12 Luminex Lot Number 032521023E, FLOQSwab Lot Number: 2100856 13 Luminex Lot Number 033021023E, FLOQSwab Lot Number: 2100856 14 Luminex Lot Number 041421023F, FLOQSwab Lot Number: 2100856 15 Luminex Lot Number 050521023H, FLOQSwab Lot Number: 2100856 16 Luminex Lot Number 050621023C, FLOQSwab Lot Number: 2032870 17 Luminex Lot Number 051221023E, FLOQSwab Lot Number: 2100856 18 Luminex Lot Number 051221023F, FLOQSwab Lot Number: 2100856, 2032870 19 Luminex Lot Number 051721023B, FLOQSwab Lot Number: 2100856, 2032870 20 Luminex Lot Number 052721023D, FLOQSwab Lot Number: 2107946 - Amount recalled
- 5601 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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