Recall Z-0359-2027 ยท NSU Instrumentation For Clinical Multiplex Test Systems
Luminex Corporation
LIAISON PLEX Gram-Negative Blood Culture Assay Catalog No. 20-005-303
| Date | Nov 5, 2026 (initiated Oct 5, 2026) |
| Status | Open, Classified |
| 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 |
| Action | On October 5, 2026, the firm began notifying customers via "Urgent Field Safety Notice - Medical Device Recall" letters. Consignees were informed that the current Instructions for Use for the Gram-Negative Blood Culture Assay do not adequately describe interpretation of certain positive family-level results. Specifically, when a positive family-level only result is obtained ("family-level only result" refers to a positive organism family-level detection without an accompanying genus- or species-level identification), repeat testing with the LIAISON PLEX Gram-Negative Blood Culture Assay is re |
| Quantity | 30,168 test cartridges (2,514 Kits) |
| Distribution | US distribution nationwide. No OUS distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K243013 | LIAISON PLEX Gram-Negative Blood Culture Assay Luminex Corporation, Apr 18, 2025 |