NxTAG Respiratory Pathogen Panel, REF: I051C0447 recallZ-0042-2025 · Luminex Molecular Diagnostics Inc · initiated Sep 5, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Luminex Molecular Diagnostics Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
On 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 [email protected] 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). [email protected] www.diasorin.com
Recall details
- Recall number
- Z-0042-2025
- Status
- Open, Classified
- Initiated by the company
- Sep 5, 2024
- Posted by the FDA
- Oct 9, 2024
- Recalling firm
- Luminex Molecular Diagnostics Inc
- Quantity
- 3375
- Product code
- OCC
- FDA submissions
- K193167, K152386
- Distribution
- U 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.
Product description
NxTAG Respiratory Pathogen Panel, REF: I051C0447
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- NxTAG® Respiratory Pathogen Panel I051C0447Luminex Molecular Diagnostics, Inc · Non-sars coronavirus multiplex nucleic acid assay1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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