FDA recall Z-1767-2019

Luminex Molecular Diagnostics · Class II · device

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.

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.

Key facts

Status
Ongoing
Initiation date
2019-02-22
Report date
2019-06-19
Voluntary/Mandated
Voluntary: Firm initiated
Location
Toronto, N/A, Canada

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1767-2019