LIAISON PLEX Gram-Negative Blood Culture Assay Catalog No. 20-005-303
Luminex Corporation · Instructions for Use updated to include explicit guidance that repeat testing is recommended whenever a positive family-level only result is obtained. Issue ma…
Open FDA's page for this record- Cfres ID
- 223172
- Product res number
- Z-0359-2027
- Event date initiated
- 2026-10-05
- Event date posted
- 2026-11-05
- Recall status
- Open, Classified
- Res event number
- 100036
- Product code
- NSU
- Product description
- LIAISON PLEX Gram-Negative Blood Culture Assay Catalog No. 20-005-303
- Code info
- All lots UDI-DI pending
- Firm FEI number
- 3006028115
- Recalling firm
- Luminex Corporation
- Address 1
- 4088 Commercial Ave
- City
- Northbrook
- State
- IL
- Postal code
- 60062-1829
- Additional info contact
- Technical Support 877-785-2323 Ext. 9029
- Root cause description
- Error in labeling
- Product quantity
- 30,168 test cartridges (2,514 Kits)
- Distribution pattern
- US distribution nationwide. No OUS distribution.
- Reason for recall
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.
- 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 recommended. Absence of this instruction may increase the likelihood that certain reportable detections are not appropriately recognized by the user and may contribute to an incorrect interpretation of test results. Customers were instructed to implement the following interpretation guidance: When a positive family-level only result is obtained, repeat testing with the LIAISON PLEX BCN assay is recommended. DiaSorin is updating the Instructions for Use to include the revised guidance. Revised labeling will be provided following implementation of the labeling revision. Please contact Technical Support Services with any questions or concerns at the following phone numbers:1-877-785-2323 (U.S. and Canada); +1-512-381-4397 (Outside U.S. and Canada); 1-512-219-5114 (Fax) and email:support@luminexcorp.com.
- K numbers
- K243013
- Harmonized identifiers (openFDA)
- Device name
- Instrumentation For Clinical Multiplex Test Systems
- Medical specialty description
- Clinical Chemistry
- Regulation number
- 862.2570
- Device class
- 2
- K number
- K121399, K093128, K143178, K110786, K133302, DEN040012, K082562, K141220, K070597, K080995, K073506, K163652, K133849
- Registration number
- 3009189893, 3021389305, 3003366417, 3013540184, 3002773840, 2243471, 3008632402, 3005269352, 3010461097, 3038610665, 3017358793, 3016611336, 8043379, 1650733, 3005967741, 3007118747, 8020030, 3003673482, 3007208259, 3004530258, 1628664, 3035381641, 2024800, 3017907743, 3014515702, 2183715, 3007420875, 3007361513, 9615056, 3010286073, 3006198300, 3003795116, 3042641161, 9610126, 3010770794, 2032682, 3007143373, 3006028115, 3012259842, 3005370583 +23 more
- FEI number
- 3009189893, 3021389305, 3003366417, 3013540184, 3002773840, 3006461677, 2243471, 3008632402, 3005269352, 3010461097, 3038610665, 3017358793, 3016611336, 3005967741, 3007118747, 3007208259, 3003673482, 3004530258, 1628664, 3035381641, 2024800, 3002806559, 3017907743, 3014515702, 1000186023, 2183715, 3008272466, 3003952975, 3007420875, 3007361513, 3010286073, 3006198300, 3003795116, 3042641161, 3002524000, 3010770794, 3007143373, 3006028115, 3012259842, 3005370583 +23 more