FDA Device recall Z-0500-2024
Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Lum…
- FDA Device
- Class II
- ongoing
- Published 2023-12-13
On 2023-12-13 the FDA classified a Class II recall of Luminex VERIGENE BC-GP Utility Tray (5-Pack Carrier), Gram-Positive Blood Culture Nucleic Acid Test, REF 20-011-018, a component of the Lum… by Luminex, citing potentially defective utility trays in the reagent kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0500-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-11-07 |
| Published | 2023-12-13 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Luminex |
| Distribution | US |
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
Potentially defective utility trays in the reagent kits.
Identifiers
| code_info | Lot number 062123018C, Exp. 12/20/2023, UDI (01)00840487101674(17)231220(10)062123018C. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0500-2024%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.