Verigene Processor SP — Class II medical device recall Z-1092-2022
Ongoing recall by Luminex Corporation, reported 2022-05-25, distributed in AZ, CA, CO, FL, GA, IL, IN, KY…. Heater within the Verigene System may be outside of established temperature limits for assays which could resu
| Recall number | Z-1092-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Austin, TX, United States |
| Recall initiated | 2022-04-05 |
| Classified | 2022-05-13 |
| Reported by FDA | 2022-05-25 |
| Distributed | AZ, CA, CO, FL, GA, IL, IN, KY, ME, MI, NE, OH, PA, TX, VT, WA |
| Quantity | 24 units |
| Serial numbers | 10-0000-07, 11250096, 12061048, 13051068, 13193254, 14069051, 16277059, 17340003, 18128002, 18191010, 18214004, 18255003, 19044007, 19233005, 20133004, 21029902 |
| Model numbers | 10-0000-07/10-0000-07R |
Product
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
Reason for recall
Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.
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-1092-2022. 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.