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 | Ongoing |
| Reason | A part defect with the wash 1 syringe of an SARS-CoV-2 assay could lead to incomplete extraction thereby producing an invalid or false negative assay result. |
| Product | ARIES SARS-CoV-2 Assay, REF: 50-10047 |
| Quantity | 5,141 (24 Cassettes) |
| Distribution | Distribution US nationwide, Indonesia, and Hong Kong. |
| Initiated | 2022-09-14 |
| Classified | 2022-10-26 |
| Recall number | Z-0134-2023 |
| 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-0134-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90937/
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