VERIGENE Processor SP Model No — Class II medical device recall Z-0054-2021
Ongoing recall by Luminex Corporation, reported 2020-10-14. No results/incorrect results due to failure of the hybridization heater.
| Recall number | Z-0054-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Austin, TX, United States |
| Recall initiated | 2018-12-10 |
| Classified | 2020-10-05 |
| Reported by FDA | 2020-10-14 |
| Quantity | 1 systems |
| UPC / GTIN / UDI-DI | 00857573006010 |
| Serial numbers | 14230205 |
| Model numbers | 10-0000-07 |
Product
VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
Reason for recall
No results/incorrect results due to failure of the hybridization heater.
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-0054-2021. 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.