Luminex VERIGENE BC-GP Utility Tray — Class II medical device recall Z-0500-2024
Ongoing recall by Luminex Corporation, reported 2023-12-13, distributed nationwide. Potentially defective utility trays in the reagent kits.
| Recall number | Z-0500-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Northbrook, IL, United States |
| Recall initiated | 2023-11-07 |
| Classified | 2023-12-06 |
| Reported by FDA | 2023-12-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | IT |
| UPC / GTIN / UDI-DI | 00840487101674 |
| Lot numbers | 062123018C |
| Model numbers | 20-011-018, 20-012-018 |
| Expiration dates | 2023-12-20 |
Product
Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Luminex VERIGENE BC-GP Utility Kit, REF 20-012-018, containing 20 tests.
Reason for recall
Potentially defective utility trays in the reagent kits.
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-0500-2024. 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.