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U.S. Department of Health and Human Services

Class 2 Device Recall NxTAG Respiratory Pathogen Panel

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 Class 2 Device Recall NxTAG Respiratory Pathogen Panelsee related information
Date Initiated by FirmSeptember 05, 2024
Date PostedOctober 09, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0042-2025
Recall Event ID 95377
510(K)NumberK152386 K193167 
Product Classification Respiratory virus panel nucleic acid assay system - Product Code OCC
ProductNxTAG Respiratory Pathogen Panel, REF: I051C0447
Code Information UDI-DI: 00840487100417. Lot/Expiration: IK051C-0181/ 9/30/2024, IK051C-0182/ 9/30/2024, IK051C-0185/ 9/30/2024, IK051C-0186/ 9/30/2024, IK051C-0187/ 10/31/2024, IK051C-0188/ 10/31/2024, IK051C-0189/ 10/31/2024, IK051C-0190/ 10/31/2024, IK051C-0191/ 10/31/2024, IK051C-0192/ 10/31/2024, IK051C-0193/ 10/31/2024, IK051C-0194/ 10/31/2024, IK051C-0195/ 10/31/2024, IK051C-0196/ 11/30/2024, IK051C-0197/ 12/31/2024
FEI Number 3002777243
Recalling Firm/
Manufacturer		 Luminex Molecular Diagnostics Inc
439 University Ave Suite 900
Toronto Canada
Manufacturer Reason
for Recall		Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.
FDA Determined
Cause 2		Device Design
ActionOn 9/5/24, recall notices were sent to customers and distributors were were asked to do the following: 1. Two options are available to overcome the sporadic potential risk of the hMPV false positive result: A. Continue to use the product as per its instruction for use: in case of a positive result for hMPV, consider performing confirmatory testing with another method before reporting the hMPV result, if medically indicated. B. Exclude the hMPV from the reporting by removing this target from the assay analysis, as explained in the package insert under the chapter "Define Test Panels in SYNCT Software". See Document No. and Revision/Page reference: MLD-051-KPI-001 Rev H/Page 17, MLD-056-KPI-001 Rev. E/Page 18. 2. Notify others within your network that may have remaining inventory of those kits. 3. If you are a distributor, provide a copy of this letter to customers or organizations who received impacted lots. 4. Complete and return the response form via email to support@luminexcorp.com 5. For complaints, questions, or concerns, please contact Technical Support using the contact information: 1-877-785-2323 (U.S. and Canada). +1-512-381-4397 (Outside U.S. and Canada). 1-512-219-5114 (Fax). support@luminexcorp.com www.diasorin.com
Quantity in Commerce3375
DistributionU Nationwide distribution in the states of OH, CA, NC, WI, TN, TX, MI, NY, MO, FL, MA, NJ, PA, VA, AZ, IL, OK, CO, MN.
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 = OCC
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