Z-1767-2019Class II

xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification...

Name: Z-1767-2019 xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification...
Creator: Luminex Molecular Diagnostics
Published: 2019-02-22
License: https://open.fda.gov/license/

Luminex Molecular Diagnostics Inc / initiated 2019-02-22 / Open, Classified / root cause: manufacturing process

FDA source

Luminex Molecular Diagnostics began a recall of xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic... on 2019-02-22. FDA classified it as Class II and gives the reason as "Reports have been received of lower MS2 MFI values when using the panel". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1767-2019
Classification: Class II
Status: Open, Classified
Initiated: 2019-02-22
Posted: 2019-06-10
Recalling firm: Luminex Molecular Diagnostics Inc
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.
Product code: PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Reason for recall: Reports have been received of lower MS2 MFI values when using the panel.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm issued letters via email dated 2/22/2019.
Quantity in commerce: 965 kits
Distribution: 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.
Product codes and lots: Lot numbers IK032C-00061, exp. 11/30/2018; IK032C-00063, exp. 11/30/2018; IK032C-00064, exp. 12/31/2018; IK032C-00066, exp. 12/31/2018; IK032C-00067, exp. 11/30/2018; IK032C-00068, exp. 4/30/2019; IK032C-00069, exp. 7/31/2019; and IK032C-00071, exp. 12/31/2018; UDI 00840487100493.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1767-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1767-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-06-19	2019-06-10

Product code PCH

K140377Class IIXtag Gastrointestinal Pathogen Panel (Gpp)/xtag Data Analysis Software for Gpp (Tdas Gpp)Luminex Molecular Diagnostics, Inc. / cleared 2014-09-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)