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xTAG® Gastrointestinal Pathogen Panel (GPP) I032C0316Recalls & reported problems

Luminex Molecular Diagnostics, Inc · The xTAG® Gastrointestinal Pathogen Panel (GPP) is a qualitative multiplex test intended for the simultaneous detection and identification of nucleic acids from multiple gastroenteritis causing viruses, parasites and bacteria (including toxin gene detection) in human stool samples that are fresh, frozen or in a holding medium, from individuals with signs and symptoms of infectious colitis or gastroenteritis. · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

  1. Feb 22, 2019Open, Classified

    Reports have been received of lower MS2 MFI values when using the panel.

    Z-1767-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Other Gastrointestinal pathogen panel multiplex nucleic acid-based assay system devices

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page