ARIES HSV 1&2 Assay — Class II medical device recall Z-0553-2022
Terminated recall by Luminex Corporation, reported 2022-02-09, distributed nationwide. Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes co
| Recall number | Z-0553-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Austin, TX, United States |
| Recall initiated | 2021-11-17 |
| Classified | 2022-02-02 |
| Reported by FDA | 2022-02-09 |
| Terminated | 2024-07-08 |
| Distributed | Nationwide (US) |
| Countries outside the US | MX, MY |
| Quantity | 329 |
| Reason classes | packaging |
| Lot numbers | AB3560A, AB3600A |
| Model numbers | 50-10017 |
Product
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Reason for recall
Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid.
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-0553-2022. 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.