xTAG Gastrointestinal Pathogen Panel intended for the simultaneous… — Class II medical device recall Z-1767-2019
Ongoing recall by Luminex Molecular Diagnostics, reported 2019-06-19, distributed in AL, AR, AZ, CA, FL, GA, IL, IN…. Reports have been received of lower MS2 MFI values when using the panel.
| Recall number | Z-1767-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Molecular Diagnostics, Toronto, N/A, Canada |
| Recall initiated | 2019-02-22 |
| Classified | 2019-06-10 |
| Reported by FDA | 2019-06-19 |
| Distributed | AL, AR, AZ, CA, FL, GA, IL, IN, MO, NC, ND, NJ, NY, OK, TN, TX, VA, WI |
| Quantity | 965 kits |
| UPC / GTIN / UDI-DI | 00840487100493 |
| Lot numbers | IK032C-00061, IK032C-00063, IK032C-00064, IK032C-00066, IK032C-00067, IK032C-00068, IK032C-00069, IK032C-00071 |
| Model numbers | I032C0316 |
| Expiration dates | 2018-11-30, 2018-12-31, 2019-04-30, 2019-07-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1767-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.