FDA Device recall Z-1767-2019
xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial an…
- FDA Device
- Class II
- ongoing
- Published 2019-06-19
On 2019-06-19 the FDA classified a Class II recall of xTAG Gastrointestinal Pathogen Panel intended for the simultaneous qualitative detection and identification of multiple viral, bacterial an… by Luminex Molecular Diagnostics, citing reports have been received of lower MS2 MFI values when using the panel.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1767-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-02-22 |
| Published | 2019-06-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Luminex Molecular Diagnostics |
| Distribution | AL, AR, AZ, CA, FL, GA, IL, IN, MO, NC, ND, NJ, NY, OK, TN, TX, VA, WI |
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
Reports have been received of lower MS2 MFI values when using the panel.
Identifiers
| code_info | Lot numbers IK032C-00061, exp. 11/30/2018; IK032C-00063, exp. 11/30/2018; IK032C-00064, exp. 12/31/2018; IK032C-00066,…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1767-2019%22
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