Home / Recalls / Lusys Laboratories, Inc. / Z-1333-2015

Z-1333-2015 Class I Terminated

Recalled by Lusys Laboratories, Inc. — San Diego, CA

Recall Details

Product Type
Devices
Report Date
April 15, 2015
Initiation Date
March 13, 2015
Termination Date
May 31, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
20 units

Product Description

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.

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.

Distribution Pattern

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

Code Information

Lot No. 12292014B

Other recalls by Lusys Laboratories, Inc.

  • Z-0717-2022 Class I — Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutan (January 13, 2022)
  • Z-0718-2022 Class I — COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies (January 13, 2022)
  • Z-0716-2022 Class I — LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: (January 13, 2022)
  • Z-1330-2015 Class I — Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Material (March 13, 2015)
  • Z-1331-2015 Class I — Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus tes (March 13, 2015)
  • Z-1334-2015 Class I — Ebola Virus Antigen Blood, Catalog No. I-123 (A) Materials Provided: 1. Test (March 13, 2015)
  • Z-1328-2015 Class I — Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Prov (March 13, 2015)
  • Z-1329-2015 Class I — Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Prov (March 13, 2015)
  • Z-1332-2015 Class I — Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus (March 13, 2015)
  • Z-1335-2015 Class I — Ebola Virus GP-VP IgS, Catalog No. I-124 virus test kit (March 13, 2015)