Verigene Processor SP with assay: Luminex — Class II medical device recall Z-2775-2020
Terminated recall by Luminex Corporation, reported 2020-08-19, distributed nationwide. An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) f
| Recall number | Z-2775-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Austin, TX, United States |
| Recall initiated | 2020-06-15 |
| Classified | 2020-08-10 |
| Reported by FDA | 2020-08-19 |
| Terminated | 2023-06-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, BG, CA, CL, CN, DE, ES, FR, GB, GR, HK, IT, JP, KR, KW, MX, NL, NZ, RU, SA, SG, TH, TR |
| UPC / GTIN / UDI-DI | 00840487101483, 00840487101490 |
| Serial numbers | 10014001, 10014002, 10014003, 10014004, 10014005, 10014006, 10014007, 10014008, 10014009, 10014010, 10014011, 10014012, 10035013, 10035014, 10035015, 10035016, 10035017, 10035018, 10035019, 10035020, 10035105, 10035106, 10043021, 10043022, 10043023 and 475 more |
Product
Verigene Processor SP with assay: Luminex, VERIGENE Gram-Positive Blood Culture Nucleic Acid Test,BC-GP, IVD - Product Usage: utilizes a single-use disposable test consumables and a self-contained Verigene Test Cartridge for each sample tested.
Reason for recall
An instrument failure mode that may result in a Blood Culture Gram Positive (BC-GP) or Gram Negative (BC-GN) false negative call.
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-2775-2020. 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.