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Lusys Laboratories, Inc. recalls Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Provided: 1. Test Device 2. Lancet 3. Alc
Recalled April 15, 2015 · FDA recall Z-1328-2015 · 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
1,055 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 IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Provided: 1. Test Device 2. Lancet 3. Alcohol pad. 4. Develop buffer tube contain buffer vial (0.3ml)
Manufacturer(s)
Lusys Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →