Luminex Corporation: Instrumentation For Clinical Multiplex Test Systems
- Recalling firm
- Luminex Corporation
- Product
- LIAISON PLEX Gram-Negative Blood Culture Assay Catalog No. 20-005-303
- 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.
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-10-05
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US distribution nationwide. No OUS distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/1ac14c35-7229-43ff-8888-19604ab220d4