Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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.

FDA Recall Z-1767-2019 · Posted None

Recalling FirmLuminex Molecular Diagnostics
Recall StatusOpen, Classified
Product CodePCH
Date Initiated2019-02-22
Product Quantity965 kits

Reason for Recall

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

Firm Action

The recalling firm issued letters via email dated 2/22/2019.

Root Cause

Nonconforming Material/Component

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑