Verigene Gram Positive Blood Culture — Class II medical device recall Z-2533-2024
Ongoing recall by Luminex Corporation, reported 2024-08-14, distributed nationwide. Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugd
| Recall number | Z-2533-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Luminex Corporation, Northbrook, IL, United States |
| Recall initiated | 2024-06-20 |
| Classified | 2024-08-08 |
| Reported by FDA | 2024-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 1,100 kits |
| Pathogens | staphylococcus |
| UPC / GTIN / UDI-DI | 00840487101575 |
| Lot numbers | 031824018A |
| Model numbers | 20-006-018 |
| Expiration dates | 2024-09-16 |
Product
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Reason for recall
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
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-2533-2024. 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.