Luminex xTAG Gastrointestinal Pathogen Panel Recalled for Lower MS2 MFI Values
Luminex Molecular Diagnostics is recalling 965 xTAG Gastrointestinal Pathogen Panel kits due to reports of lower MS2 MFI values.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any hospitalizations, significant injuries, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Luminex Molecular Diagnostics is recalling 965 units of the xTAG Gastrointestinal Pathogen Panel (GPP) Kit, IVD, REF I032C0316. The recall is being conducted because reports have been received of lower MS2 MFI values when using the panel.
The affected lots are IK032C-00061, IK032C-00063, IK032C-00064, IK032C-00066, IK032C-00067, IK032C-00068, IK032C-00069, and IK032C-00071. These lots have expiration dates ranging from November 30, 2018, to July 31, 2019. The UDI for the product is 00840487100493.
Distribution from the firm's Austin, Texas, location was made to Alabama, Arkansas, Arizona, California, Florida, Georgia, Illinois, Indiana, Missouri, North Carolina, North Dakota, New Jersey, New York, Oklahoma, Tennessee, Texas, Virginia, and Wisconsin. There was military distribution but no government distribution. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled kits.
The recalled product
- 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.
- Manufacturer
- Luminex Molecular Diagnostics
- Hazard
- Affected units
- 965
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- Lot numbers IK032C-00061
- exp. 11/30/2018
- IK032C-00063
- IK032C-00064
- exp. 12/31/2018
- IK032C-00066
- IK032C-00067
- IK032C-00068
- exp. 4/30/2019
- IK032C-00069
- exp. 7/31/2019
- and IK032C-00071
- UDI 00840487100493.
Distribution
Related recalls
Same manufacturer · Luminex Molecular Diagnostics
See all →- HighLuminex xTAG Respiratory Viral Panel Recalled for False Negative Results
FDA (Devices) · 2019-10-30
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- HighRespiratory Pathogen Panel Recalled Due to False Positive Results
FDA (Devices) · 2024-10-16
- HighLuminex xTAG Respiratory Viral Panel Recalled for False Negative Results
FDA (Devices) · 2019-10-30
- HighMedical Device Recall: Respiratory Panel May Report Incorrect hMPV Results
FDA (Devices) · 2024-10-16
- ModerateBioFire FilmArray Gastrointestinal Panel Recalled for False Positive Results
FDA (Devices) · 2019-05-08
- HighBioFire FilmArray Gastrointestinal Panel Recalled for False Negative Results
FDA (Devices) · 2020-03-18
- HighDiagnostic Test Kits for GI Panel May Return False Negatives Due to Manufacturing Issue
FDA (Devices) · 2024-01-17