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 | Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results. |
| Product | Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system |
| Quantity | 24 units |
| Distribution | US:OH, ME, PA, FL, IL, NE, IN, TX, GA, WA, MI, CO, AZ, OH, KY, CA, VT OUS: None |
| Initiated | 2022-04-05 |
| Classified | 2022-05-13 |
| Recall number | Z-1092-2022 |
| 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-1092-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90023/
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