FDA recall, , Moderate risk
Luminex LIAISON PLEX Gram-Negative Blood Culture Assay
The Liaison Plex Gram-Negative Blood Culture Assay may cause incorrect or delayed diagnosis of bloodstream infection.
Summary by Recall Canary from the FDA notice
What happened
Luminex Corporation of Northbrook, Illinois, voluntarily recalled the LIAISON PLEX Gram-Negative Blood Culture Assay Catalog No. 20-005-303. The recall was firm initiated and began on October 5, 2026, and was added to the FDA's Enforcement Report and classified on November 5, 2026.
The agency stated that the Instructions for Use were updated to include explicit guidance that repeat testing is recommended whenever a positive family-level only result is obtained, and the issue may contribute to incorrect or delayed diagnosis of bloodstream infection.
The product was distributed nationwide in the US, with no OUS distribution.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
Liaison Plex Gram-Negative Blood Culture Assay Catalog No. 20-005-303
- Lot code
- All lots UDI-DI pending
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Nov 2, 2026
- Sold in
US distribution nationwide. No outside the U.S. distribution.
- Recalled by
- Luminex CorporationNorthbrook, Illinois
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 100036
- Recall number
- Z-0359-2027
- Quantity recalled
- 30,168 test cartridges (2,514 Kits)
- Recall type
- Voluntary: Firm initiated
All recalls from Luminex Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Luminex began the recall
FDA posted the recall to its Enforcement Report and rated it Class II (moderate risk)
Added to Recall Canary
