Z-1767-2019 Class II Ongoing
FDA device recall Z-1767-2019 was initiated by Luminex Molecular Diagnostics on February 22, 2019 and is designated Class II. Reason for recall: Reports have been received of lower MS2 MFI values when using the panel. The recall status is ongoing. Affected quantity: 965 kits.
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.