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FDAFebruary 22, 2019device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

luminex molecular diagnosticsluminexluminex molecular

UPCs

00840487100493

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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