Class II — Luminex Corporation
| Recalling firm | Luminex Corporation |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Impacted lot may leak inside the ARIES instrument. |
| Product | ARIES HSV 1&2 Assay, Part Number/REF 50-10017 |
| Quantity | 296 kits |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Alabama, California, Georgia, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Vermont, Virginia, Washington, Wisconsin and the country of Taiwan. |
| Initiated | 2021-04-16 |
| Classified | 2022-01-14 |
| Terminated | 2024-09-20 |
| Recall number | Z-0498-2022 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Luminex Corporation (Z-0498-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89303/
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