The Recall Desk

Manufacturer

Luminex Molecular Diagnostics

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

What the numbers show

Total
2
Critical
0
Severe
0
Most recent
2019-10-30

Of the 2 recalls from Luminex Molecular Diagnostics 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-0161-2020·2019-10-30

    Luminex xTAG Respiratory Viral Panel Recalled for False Negative Results

    Luminex Molecular Diagnostics is recalling xTAG Respiratory Viral Panel kits because they may produce false negative results for Influenza A (H3) and RSV A.

    Product
    xTAG Respiratory Viral Panel (RVP): Box Label: xTAG RVP (Respiratory Viral Panel). Catalogue Number:I019C0111 in vitro diagnostic test
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-1767-2019·2019-06-19

    Luminex xTAG Gastrointestinal Pathogen Panel Recalled for Lower MS2 MFI Values

    Luminex Molecular Diagnostics is recalling 965 xTAG Gastrointestinal Pathogen Panel kits due to reports of lower MS2 MFI values.

    Product
    xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool (GPP) Kit, IVD, REF I032C0316.
    Category
    Medical Device
    Distribution
    18 states