The Recall Desk

Manufacturer

Luminex Molecular Diagnostics Inc

2 recalls in our database name Luminex Molecular Diagnostics Inc as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2024-10-16

Of the 2 recalls from Luminex Molecular Diagnostics Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–2 of 2

  • HighFDA (Devices)·Z-0042-2025·2024-10-16

    Respiratory Pathogen Panel Recalled Due to False Positive Results

    The NxTAG Respiratory Pathogen Panel is recalled due to false positive results for human metapneumovirus in about 7.6% of samples, especially those positive for other respiratory pathogens.

    Product
    NxTAG Respiratory Pathogen Panel, REF: I051C0447
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0043-2025·2024-10-16

    Medical Device Recall: Respiratory Panel May Report Incorrect hMPV Results

    The NxTAG Respiratory Pathogen Panel may produce false positive results for human Metapneumovirus (hMPV), potentially leading to incorrect co-infection diagnoses.

    Product
    NxTAG Respiratory Pathogen Panel +SARS-CoV-2, REF: I056C0468
    Category
    Medical Device
    Distribution
    Distributed nationwide