Verigene Respiratory Pathogens Flex Nucleic Acid Test — Class II medical device recall Z-2006-2021
Ongoing recall by Luminex Corporation, reported 2021-07-14, distributed nationwide. Potential for a false-negative result.
| Recall number | Z-2006-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Northbrook, IL, United States |
| Recall initiated | 2020-10-30 |
| Classified | 2021-07-02 |
| Reported by FDA | 2021-07-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CL, DE, ES, FR, GB, GR, IT, JP, KW, NL, TH, TR |
| Quantity | 38,990 |
| Model numbers | 20-006-024 |
Product
Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model Number: 20-006-024
Reason for recall
Potential for a false-negative result.
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-2006-2021. 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.