Luminex Molecular Diagnostics recalls xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple…

Recall date

February 22, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1767-2019

FDA classification

Class II

Brand / firm

Luminex Molecular Diagnostics

Sold / distributed

Distribution from the firm's Austin, Texas, location was made to AL, AR, AZ, CA, FL, GA, IL, IN, MO, NC, ND, NJ, NY, OK, TN, TX, VA, and WI. There was military distribution but no government distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.