Home / Recalls / Luminex Molecular Diagnostics Inc / Z-0043-2025

Z-0043-2025 Class II Ongoing

Recalled by Luminex Molecular Diagnostics Inc — Toronto

Recall Details

Product Type: Devices
Report Date: October 16, 2024
Initiation Date: September 5, 2024
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 613

Product Description

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

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 Pattern

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.

Code Information

Lot/Expiration: IK056C-0033/ 9/30/2024, IK056C-0034/ 10/31/2024, IK056C-0035/ 10/31/2024, IK056C-0036/ 12/31/2024, IK056C-0037/ 12/31/2024, IK056C-0038/ 12/31/2024, IK056C-0039/ 1/31/2025