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.
Check against the official notice below — it lists the full affected range.
Luminex Molecular Diagnostics has recalled 965 kits of the xTAG Gastrointestinal Pathogen Panel, which is used to detect and identify viral, bacterial, and parasitic nucleic acids. The recall was issued because reports were received of lower MS2 MFI values when using the panel. The affected kits were distributed from the firm's Austin, Texas location to AL, AR, AZ, CA, FL, GA, IL, IN, MO, NC, ND, NJ, NY, OK, TN, TX, VA, and WI, including military locations. The affected lot numbers are IK032C-00061, IK032C-00063, IK032C-00064, IK032C-00066, IK032C-00067, IK032C-00068, IK032C-00069, and IK032C-00071, with expiration dates ranging from November 2018 through July 2019.
The source does not specify what remedy an affected consumer should pursue.
Written by software from the official notice below. Not reviewed by a lawyer.
Reports have been received of lower MS2 MFI values when using the panel.
Reason for recall: Reports have been received of lower MS2 MFI values when using the panel. 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. Quantity: 965 kits Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.