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FDAMarch 13, 2015device

Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test Device in foil pouch. 2. Lancet for Blood test and alcohol pad. 3. Extraction tube contain buffer vial (0.5ml) for feces test 4. Swab for Nasal test.

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Terminated

Brands named

lusys laboratorieslusys

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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