Lusys Laboratories, Inc.: 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.

Agency Publication Date: April 9, 2015

Affected Products

Product: 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)

Lot No. 12012014B

Product: 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.

Lot No. 12012014B

Product: Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged

Lot No. 11192014B

Product: Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit

Lot No. 12012014A

Product: Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit

Lot No. DEI007963

Product: Ebola Virus Antigen Nasal , Catalog No. I-123 (B) 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.

Lot No. 12292014B

Product: 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.

n/a

Product: Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit

n/a

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 70668

Status: Resolved

Manufacturer: Lusys Laboratories, Inc.

Manufactured In: United States

Units Affected: 8 products (1,055 units; 1,015 units; 80 units; 40 units; 20 units; 20 units; 5 units; 40 units)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Affected Products

Product: 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)

Lot No. 12012014B

Lot No. 11192014B

Product: Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus test kit

Lot No. 12012014A

Product: Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus test kit

Lot No. DEI007963

Lot No. 12292014B

n/a

Product: Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit

n/a