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.
The devices described in this recall notice are the same ones that were announced in the FDA safety communication, Stop Using LuSys Laboratories COVID-19 Tests, from January 2022.
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
Device Use
The LuSys Laboratories COVID-19 Antigen Test uses a nasal swab, or a saliva (spit) sample intended to detect proteins, called antigens, on the SARS-CoV-2 virus.
The LuSys Laboratories COVID-19 IgG/IgM Antibody Test uses serum, plasma, or blood samples to look for antibodies produced by a person's immune system in response to SARS-CoV-2, the virus that causes COVID-19, suggesting a recent or previous infection. Antibody tests should not be used to diagnose or exclude an active COVID-19 infection.
The LuSys Laboratories COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests may also be sold under the company names Luscient Diagnostics, Vivera Pharmaceuticals, or with the trade name EagleDx.
Reason for Recall
LuSys Laboratories is recalling these tests because they do not have an Emergency Use Authorization, 510(k), or PMA and therefore cannot be legally marketed and distributed in the United States. In addition, LuSys Laboratories did not provide appropriate validation data to show that the tests can perform accurately. This means there is a risk of potential false negative, false positive, and misinterpretation of results from these tests.
LuSys Laboratories has received no complaints or reports of injuries, deaths, or adverse events.
Who May be Affected
- People who were tested for SARS-CoV-2 using LuSys Laboratories COVID-19 Antigen Test
- Health care providers and other organizations who used the LuSys Laboratories COVID-19 Antigen Test
What to Do
On January 13, 2022, and January 24, 2022, LuSys Laboratories sent Urgent Medical Device Recall letters to device customers, distributors, and other U.S. consignees requesting them to take the following actions:
- Immediately stop using these tests
- If the tests were distributed to third parties, immediately provide all consignees with a copy of this recall notification.
- Discard, destroy, or return all COVID-19 tests manufactured or distributed by LuSys Laboratories, Inc., a.k.a. Luscient Diagnostics LLC;
Contact Information
Customers in the U.S. with questions about this recall should contact LuSys Laboratories by phone at 858-733-2128 or email at onestep@lusyslab.com.
Additional Resources:
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.