Lusys Laboratories, Inc. recalls Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (optional)…

Recall date

March 13, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1329-2015

FDA classification

Class I

Brand / firm

Lusys Laboratories, Inc.

Sold / distributed

Worldwide Distribution - US including CA and Internationally to Canada, Sierra Leone, and Denmark.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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.