Common Sense 1
- 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 FDAThe 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.
- 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