Luminex Molecular Diagnostics Inc: Medical Device Recall in 2024 - (Recall #: Z-0043-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 5, 2024

Date Posted: October 16, 2024

Recall Number: Z-0043-2025

Event ID: 95377

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.

Status: Ongoing

Product Quantity: 613

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated