Home / Recalls / Lusys Laboratories, Inc. / Z-0718-2022

Z-0718-2022 Class I Ongoing

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

Recall Details

Product Type
Devices
Report Date
March 16, 2022
Initiation Date
January 13, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
33,955 kits

Product Description

COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111

Reason for Recall

COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S.

Distribution Pattern

Worldwide - US Nationwide distribution in the states of CA, NC, NV, OH, TN and TX. The countries of Canada, China, and Mexico. Pending additional information for a complete Consignee Listing

Code Information

Part Number: I-111 Lot Numbers: All Lots due to not having an authorized Emergency Use Authorization (EUA)

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-0716-2022 Class I — LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: (January 13, 2022)
  • 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)
  • Z-1330-2015 Class I — Ebola VP-40 IgG/IgM (Blood Serum/Plasma/Cassette), Catalog No. I-102 Material (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-1329-2015 Class I — Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Prov (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-1331-2015 Class I — Ebola GP IgM Blood (Blood Serum/Plasma/Cassette), Catalog No. I-103 virus tes (March 13, 2015)
  • Z-1333-2015 Class I — Ebola Virus Antigen Nasal , Catalog No. I-123 (B) Materials Provided: 1. Tes (March 13, 2015)