Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection Recalled by Luminex Molecular Diagnostics Due to Reports have been received of lower MS2 MFI...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Luminex Molecular Diagnostics directly.
Affected 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.
Quantity: 965 kits
Why Was This Recalled?
Reports have been received of lower MS2 MFI values when using the panel.
Where Was This Sold?
This product was distributed to 18 states: AL, AZ, AR, CA, FL, GA, IL, IN, MO, NJ, NY, NC, ND, OK, TN, TX, VA, WI
About Luminex Molecular Diagnostics
Luminex Molecular Diagnostics has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report