FDA-Device2015-04-15Class I
Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged
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
80 units
Manufactured in
10054 Mesa Ridge Ct Ste 118-120, N/A, San Diego, CA, United States
Products
Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1330-2015Don't want to check this manually?
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