Home / Recalls / Luminex Molecular Diagnostics / Z-1767-2019

Z-1767-2019 Class II Ongoing

Recalled by Luminex Molecular Diagnostics — Toronto, N/A

Recall Details

Product Type: Devices
Report Date: June 19, 2019
Initiation Date: February 22, 2019
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 965 kits

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.

Reason for Recall

Reports have been received of lower MS2 MFI values when using the panel.

Distribution Pattern

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.

Code Information

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.