FDA-Device2019-06-19Class II
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.
Luminex Molecular Diagnostics
Hazard
Reports have been received of lower MS2 MFI values when using the panel.
Sold states
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.
Affected count
965 kits
Manufactured in
439 University Ave Suite 900, N/A, Toronto, N/A, Canada
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1767-2019Don't want to check this manually?
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