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Luminex Molecular Diagnostics recalls xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple
Recalled June 19, 2019 · FDA recall Z-1767-2019 · Luminex Molecular Diagnostics
Hazard
Reports have been received of lower MS2 MFI values when using the panel. · FDA Class II
Units
965 kits
Sold at
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.
Description
Reports have been received of lower MS2 MFI values when using the panel.
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.
Manufacturer(s)
Luminex Molecular Diagnostics
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →