VERIGENE Gram Negative Blood Culture — Class II medical device recall Z-1903-2025
Completed recall by Luminex Corporation, reported 2025-06-11, distributed nationwide. It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on
| Recall number | Z-1903-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Northbrook, IL, United States |
| Recall initiated | 2025-04-16 |
| Classified | 2025-06-03 |
| Reported by FDA | 2025-06-11 |
| Distributed | Nationwide (US) |
| Quantity | 89 units |
| UPC / GTIN / UDI-DI | 00840487101599 |
| Lot numbers | 022525021A |
| Model numbers | 20-006-021 |
| Expiration dates | 2025-08-26 |
Product
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021; for use with the sample-to-results VERIGENE System; invitro diagnostic test
Reason for recall
It was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test cartridges.
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-1903-2025. 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.