Device product
Ebola Virus Antigen Blood, Catalog No. I-123 (A) 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.
Z-1334-2015
Product summary
- Event
- Event 70668
- Status
- Terminated
- Classification
- Class I
- Quantity
- 5 units
- Official record key
device-enforcement:Z-1334-2015
Official wording
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.
Code information: n/a
Distribution pattern: Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
Derived failure modes
-
Unknown
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.