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Lusys Laboratories, Inc. recalls Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for B
Recalled April 15, 2015 · FDA recall Z-1334-2015 · Lusys Laboratories
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. · FDA Class I
Units
5 units
Sold at
Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.
Description
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.
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.
Manufacturer(s)
Lusys Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →