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FYI - LuSys Laboratories, Inc Recalls COVID-19 Antigen Tests (Nasal/Saliva)

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Jul 8, 2016
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LuSys Laboratories, Inc Recalls COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests Because They Are Not Authorized, Cleared, or Approved by the FDA​

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product​

  • Product Names:
    • COVID-19 Antigen Test (Saliva)
    • COVID-19 Antigen Test (Nasal)
    • COVID-19 IgG/IgM Antibody Test
  • Product Codes:
  • Distribution Dates: June 1, 2020 to July 21, 2021
  • Devices Recalled in the U.S.: 164,250
  • Date Initiated by Firm: January 13, 2022
Content current as of: 03/14/2022
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