ARIES HSV 1&2 Assay — Class II medical device recall Z-0498-2022
Terminated recall by Luminex Corporation, reported 2022-01-26, distributed nationwide. Impacted lot may leak inside the ARIES instrument.
| Recall number | Z-0498-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Austin, TX, United States |
| Recall initiated | 2021-04-16 |
| Classified | 2022-01-14 |
| Reported by FDA | 2022-01-26 |
| Terminated | 2024-09-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX, TW |
| Quantity | 296 kits |
| Reason classes | packaging |
| Lot numbers | AB1703A |
| Model numbers | 50-10017 |
Product
ARIES HSV 1&2 Assay, Part Number/REF 50-10017
Reason for recall
Impacted lot may leak inside the ARIES instrument.
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-0498-2022. 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.