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

[Common Sense 1]

FYI!

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.

LuSys Laboratories Recalls COVID-19 Antigen and Antibody Tests

LuSys Laboratories recalled these tests because they do not have an EUA, 510(k), or PMA and therefore cannot be legally marketed and distributed in the U.S.

www.fda.gov

Recalled Product​

• Product Names:
  • COVID-19 Antigen Test (Saliva)
  • COVID-19 Antigen Test (Nasal)
  • COVID-19 IgG/IgM Antibody Test
• Product Codes:
  • See Recall Database Entry
• 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