FDA Device recall Z-1903-2025
VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021
- FDA Device
- Class II
- completed
- Published 2025-06-11
On 2025-06-11 the FDA classified a Class II recall of VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test, REF 20-006-021 by Luminex, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1903-2025 |
| Classification | Class II |
| Status | completed |
| Initiated | 2025-04-16 |
| Published | 2025-06-11 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Luminex |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI/DI 00840487101599, Lot Number 022525021A, exp. 08/26/2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1903-2025%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.