FDA Device recall Z-2533-2024
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
- FDA Device
- Class II
- ongoing
- Published 2024-08-14
On 2024-08-14 the FDA classified a Class II recall of Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test by Luminex, citing potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2533-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-20 |
| Published | 2024-08-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Luminex |
| Distribution | US |
Product
Verigene Gram Positive Blood Culture (BC-GP) Nucleic Acid Test
Reason
Potential for defective test cartridges which may result in false positive results for the Staphylococcus lugdunensis and Enterococcus faecium targets.
Identifiers
| code_info | GTIN Number: 00840487101575; Catalog Number: 20-006-018; Lot Number: 031824018A; Expiration Date: 09/16/2024 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2533-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.