Verigene Processor SP — Class II medical device recall Z-0920-2022
Ongoing recall by Luminex Corporation, reported 2022-04-20, distributed in CT, LA, TX. Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Proces
| Recall number | Z-0920-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Northbrook, IL, United States |
| Recall initiated | 2019-04-22 |
| Classified | 2022-04-13 |
| Reported by FDA | 2022-04-20 |
| Distributed | CT, LA, TX |
| Quantity | 4 units |
| Serial numbers | 13042054, 16347082, 17215010, 18079010 |
| Model numbers | 10-0000-07, 10-0000-07-R |
Product
Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
Reason for recall
Two of three complaints were initiated due to the customers repeatedly obtaining No Call results on the Processor SPs in question.
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-0920-2022. 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.