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.
What this means for you
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
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