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U.S. Department of Health and Human Services

Class 2 Device Recall LIAISON PLEX GramNegative Blood Culture Assay

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 Class 2 Device Recall LIAISON PLEX GramNegative Blood Culture Assaysee related information
Date Initiated by FirmOctober 05, 2026
Date PostedNovember 05, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0359-2027
Recall Event ID 100036
510(K)NumberK243013 
Product Classification Instrumentation for clinical multiplex test systems - Product Code NSU
ProductLIAISON PLEX Gram-Negative Blood Culture Assay Catalog No. 20-005-303
Code Information All lots UDI-DI pending
FEI Number 3006028115
Recalling Firm/
Manufacturer		 Luminex Corporation
4088 Commercial Ave
Northbrook IL 60062-1829
For Additional Information ContactTechnical Support
877-785-2323 Ext. 9029
Manufacturer 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.
FDA Determined
Cause 2		Error in labeling
ActionOn 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.
Quantity in Commerce30,168 test cartridges (2,514 Kits)
DistributionUS distribution nationwide. No OUS distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = NSU
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