Recall Z-1767-2019 ยท PCH Gastrointestinal Pathogen Panel Multiplex Nucleic Acid-Based Assay System
Luminex Molecular Diagnostics
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.
| Date | Feb 22, 2019 |
| Status | Open, Classified |
| Reason | Reports have been received of lower MS2 MFI values when using the panel. |
| Root cause | Nonconforming Material/Component |
| Action | The recalling firm issued letters via email dated 2/22/2019. |
| Quantity | 965 kits |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140377 | XTAG GASTROINTESTINAL PATHOGEN PANEL (GPP)/XTAG DATA ANALYSIS SOFTWARE FOR GPP (TDAS GPP) Luminex Molecular Diagnostics, Inc., Sep 16, 2014 |