Recall Z-1767-2019— Luminex Molecular Diagnostics

Name: FDA recall Z-1767-2019
Creator: U.S. Food and Drug Administration
Published: 2019-02-22

Class II · Ongoing

Class II FDA medical device recall by Luminex Molecular Diagnostics, initiated 2019-02-22. It names one FDA 510(k) clearance: K140377. 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.. Reason: Reports have been received of lower MS2 MFI values when using the panel..

Recalling firm: Luminex Molecular Diagnostics
Classification: Class II
Status: Ongoing
Initiated: 2019-02-22
Firm location: Toronto, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K140377 — XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP)Luminex Molecular Diagnostics, Inc.·cleared 2014-09-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.