Luminex Molecular Diagnostics Inc recalls NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468

Recall date

September 5, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0043-2025

FDA classification

Class II

Brand / firm

Luminex Molecular Diagnostics Inc

Sold / distributed

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.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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