Home / Recalls / Lusys Laboratories, Inc. / Z-1335-2015

Z-1335-2015 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
40 units

Product Description

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

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

n/a

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-1333-2015 Class I — Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. Tes (March 13, 2015)
  • Z-1332-2015 Class I — Ebola Accessories assembled, self-contained package, Catalog No. I-104 virus (March 13, 2015)