FDA-Device2015-04-15Class I
Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit
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
40 units
Manufactured in
10054 Mesa Ridge Ct Ste 118-120, N/A, San Diego, CA, United States
Products
Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1335-2015Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief