xTAG Gastrointestinal Pathogen Panel intended for the… recallZ-1767-2019 · Luminex Molecular Diagnostics · initiated Feb 22, 2019
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Luminex Molecular Diagnostics or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Reports have been received of lower MS2 MFI values when using the panel.
FDA root cause category: Nonconforming Material/Component
What the company is doing
The recalling firm issued letters via email dated 2/22/2019.
Recall details
- Recall number
- Z-1767-2019
- Status
- Open, Classified
- Initiated by the company
- Feb 22, 2019
- Recalling firm
- Luminex Molecular Diagnostics
- Quantity
- 965 kits
- Product code
- PCH
- FDA submissions
- K140377
- 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 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.
Code information (models, lots, serial numbers)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- xTAG® Gastrointestinal Pathogen Panel (GPP) I032C0316Luminex Molecular Diagnostics, Inc · Gastrointestinal pathogen panel multiplex nucleic acid-based assay system1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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