FDA-Device2015-04-15Class I
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)
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
1,055 units
Manufactured in
10054 Mesa Ridge Ct Ste 118-120, N/A, San Diego, CA, United States
Products
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)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1328-2015Don't want to check this manually?
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