Verigene Processor SP — Class II medical device recall Z-0477-2021
Terminated recall by Luminex Corporation, reported 2020-12-02, distributed nationwide. Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VE
| Recall number | Z-0477-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Northbrook, IL, United States |
| Recall initiated | 2020-10-13 |
| Classified | 2020-11-20 |
| Reported by FDA | 2020-12-02 |
| Terminated | 2024-01-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CL, DE, ES, FR, GB, GR, IT, JP, KW, NL, TH, TR |
| Quantity | 2,838 units |
| Reason classes | unapproved product |
| UPC / GTIN / UDI-DI | 00857573006010 |
| Serial numbers | 10014001, 10014002, 10014003, 10014005, 10014006, 10014007, 10014008, 10014009, 10014010, 10014011, 10014012, 10035013, 10035014, 10035015, 10035016, 10035017, 10035017R, 10035018, 10035019, 10035020, 10035105, 10035106, 10043021, 10043022, 10043023 and 475 more |
| Model numbers | 10-0000-07, 10-0000-07R |
Product
Verigene Processor SP, Model Numbers 10-0000-07 and 10-0000-07R. Used with assay Luminex, VERIGENE Gram-Negative Blood Culture Nucleic Acid Test, BC-GN, IVD - Product Usage: IVD sample processor, which utilizes a single-use disposable test consumable and a self-contained Verigene Test Cartridge for each sample tested.
Reason for recall
Luminex has determined that three (3) separate test fixtures used by field service engineers to service the VERIGENE SP Processors were procured from unapproved sources and, in some cases, were manufactured using unvalidated processes. These text fixtures were used to calibrate and verify VERIGENE SP devices.
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-0477-2021. 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.