Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Ebola Virus Antigen Blood Recalled by Lusys Laboratories, Inc. Due to LuSys Laboratories is recalling Ebola Virus One Step...

Date: March 13, 2015
Company: Lusys Laboratories, Inc.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Lusys Laboratories, Inc. directly.

Affected Products

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.

Quantity: 5 units

Why Was This 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.

Where Was This Sold?

This product was distributed to 1 state: CA

Affected (1 state)Not affected

About Lusys Laboratories, Inc.

Lusys Laboratories, Inc. has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report