In the agency's Nov 11, 2026 enforcement report · Ongoing
LIAISON PLEX Gram-Negative Blood Culture Assay Catalog No. 20-005-303
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?
- LIAISON PLEX Gram-Negative Blood Culture Assay Catalog No. 20-005-303
- Lot codes and dates
- All lots UDI-DI pending
- Amount recalled
- 30,168 test cartridges (2,514 Kits)
Where it was sold
- Nationwide
Why it was recalled
Instructions for Use updated to include explicit guidance that repeat testing is recommended whenever a positive family-level only result is obtained. Issue may contribute to incorrect or delayed diagnosis of bloodstream infection.
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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