Lusys Laboratories, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1329-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: March 13, 2015

Date Posted: April 15, 2015

Recall Number: Z-1329-2015

Event ID: 70668

Reason for Recall:

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.

Status: Terminated

Product Quantity: 1,015 units

Code Information:

Lot No. 12012014B

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated