Summary
The FDA issued a Class II for NxTAG Respiratory Pathogen Panel, REF: I051C0447 by Luminex Molecular Diagnostics Inc. Reason: Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus).
Details
Source
Device Recall
External ID
Z-0042-2025
Action Date
2024-10-16
Status
Ongoing
Category
device
Product Description
NxTAG Respiratory Pathogen Panel, REF: I051C0447
Lot/Code Info: 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
Quantity Affected: 3375
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-09-05
Company
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 123 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Luminex Molecular Diagnostics Inc has 4 FDA actions in our database, including 2 recalls and 2 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Luminex Molecular Diagnostics Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Luminex Molecular Diagnostics Inc have FDA actions?
Luminex Molecular Diagnostics Inc has 4 FDA actions in our database, including 2 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0042-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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