LIAISON PLEX Gram-Negative assay needs updated testing instructions
Luminex updated the Instructions for Use for the LIAISON PLEX Gram-Negative Blood Culture Assay to say that repeat testing is recommended whenever a positive family-level-only result is obtained. FDA says the issue may contribute to incorrect or delayed diagnosis of bloodstream infection. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- Follow the updated Instructions for Use, which recommend repeat testing whenever a positive family-level-only result is obtained.
- The affected product is catalog number 20-005-303, all lots, sold as test cartridges and kits.
- The notice does not specify a remedy; contact Luminex Corporation for guidance.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- LIAISON PLEX Gram-Negative Blood Culture Assay Catalog No. 20-005-303
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Units affected
- 30,168 test cartridges (2,514 Kits)
- Illnesses reported
- None reported
- Manufactured in
- 4088 Commercial Ave, Northbrook, Illinois, United States
- Classification
- Class II
- Recall number
- Z-0359-2027
In the FDA's words
- Description
- LIAISON PLEX Gram-Negative Blood Culture Assay Catalog No. 20-005-303 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. All lots UDI-DI pending Distribution: US distribution nationwide. No OUS distribution. Affected quantity: 30,168 test cartridges (2,514 Kits)
- Hazard
- 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.