Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1767-2019 — 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.

U.S. FDA — Device Enforcement · Canada · 2019-02-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1767-2019
Date of alert: 2019-02-22
Country / jurisdiction: Canada
Risk level: Class II
Risk type: recall
Brand: Luminex Molecular Diagnostics
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 00840487100493

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1767-2019 — 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.

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