Device recall

LIAISON PLEX Gram-Negative Blood Culture Assay Catalog No. 20-005-303

FDA recall source

Recall number

Z-0359-2027

Event id

100036

Status

Open, Classified

FDA classification

Class II

Recalling firm

Luminex Corporation

Posted

Nov 5, 2026

Initiated

Oct 5, 2026

Product code

NSU

Device type

Instrumentation For Clinical Multiplex Test Systems

Reason

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.

Root cause

Error in labeling

Quantity

30,168 test cartridges (2,514 Kits)

Code info

All lots UDI-DI pending

Distribution

US distribution nationwide. No OUS distribution.

Related 510(k)s

K243013

Location

Northbrook, IL