Verigene Enteric Pathogens Nucleic Acid Test — Class II medical device recall Z-2952-2018
Terminated recall by Luminex Corporation, reported 2018-09-05, distributed in AZ, CO, CT, FL, GA, IL, IN, KS…. Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nucleic Acid Te
| Recall number | Z-2952-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Austin, TX, United States |
| Recall initiated | 2018-05-08 |
| Classified | 2018-08-30 |
| Reported by FDA | 2018-09-05 |
| Terminated | 2020-06-29 |
| Distributed | AZ, CO, CT, FL, GA, IL, IN, KS, MI, MN, MO, NH, TN, TX, UT, WI, WV |
| UPC / GTIN / UDI-DI | 00857573006041 |
| Lot numbers | 032718023A |
| Model numbers | 20-005-023, 20-006-023 |
Product
Verigene Enteric Pathogens Nucleic Acid Test (EP) for detecting and identification of pathogenic enteric bacteria, viruses, and genetic virulence markers from liquid or soft stool preserved in Cary-Blair medium, collected from individuals with signs and symptoms of gastrointestinal infection.
Reason for recall
Elevated false positive results Yersinia enterocolitica (Yersinia) from customers using the EP Nucleic Acid Test Cartridges component (20-006-023) from the Verigene EP Nucleic Acid Test Kit (20-005-023).
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-2952-2018. 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.