FDA MedWatch - COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests by LuSys Laboratories:

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TOPIC: COVID-19 Antigen Tests (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Tests by LuSys Laboratories: Class I Recall - Because They Are Not Authorized, Cleared, or Approved by the FDA 

AUDIENCE: Consumer, Patient, Health Professional

ISSUE: 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.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: 

• 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.

RECOMMENDATIONS: 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.

Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.