FDA-Device2015-04-15Class I
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.
Lusys Laboratories, Inc.
Hazard
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.
Sold states
Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
Affected count
5 units
Manufactured in
10054 Mesa Ridge Ct Ste 118-120, N/A, San Diego, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1334-2015Don't want to check this manually?
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