FDA Device recall Z-1333-2015
Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pa…
- FDA Device
- Class I
- terminated
- Published 2015-04-15
On 2015-04-15 the FDA classified a Class I recall of Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pa… by Lusys Laboratories, citing luSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, appr….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1333-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-03-13 |
| Published | 2015-04-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Lusys Laboratories |
| Distribution | CA |
Product
Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial(0.5ml) for feces test 4. Swab for Nasal test.
Reason
LuSys Laboratories is recalling Ebola Virus One Step Test Kits to stop and prevent further use of these devices. The Ebola Virus One-Step Test Kits have not yet been cleared, approved or authorized by the FDA for diagnostics purposes.
Identifiers
| code_info | Lot No. 12292014B |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1333-2015%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.