Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

NxTAG Respiratory Pathogen Panel +SARS-CoV-2 Recalled by Luminex Molecular Diagnostics Inc Due to Respiratory pathogen panel may report an elevated rate...

Date: September 5, 2024
Company: Luminex Molecular Diagnostics Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Luminex Molecular Diagnostics Inc directly.

Affected Products

NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468

Quantity: 613

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Luminex Molecular Diagnostics Inc

Luminex Molecular Diagnostics Inc has 2 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report