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FDAMarch 13, 2015device

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 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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