Home / Recalls / Medical Devices
Lusys Laboratories, Inc. recalls Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (optio
Recalled April 15, 2015 · FDA recall Z-1329-2015 · 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
1,015 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 GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged separately, and sufficient for use with up to 40 tests.
Manufacturer(s)
Lusys Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →