NEW YORK – The US Food and Drug Administration on Monday said that LuSys Laboratories is recalling its COVID-19 antigen and antibody tests because the agency has not authorized, cleared, or approved the tests.
The FDA said the recall is Class I, the most serious type.
San Diego-based LuSys is recalling its COVID-19 Antigen Test (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Test "because they do not have an Emergency Use Authorization, 510(k), or [premarket approval (PMA)] and therefore cannot be legally marketed and distributed in the United States," the FDA said in a statement.
"In addition, LuSys Laboratories did not provide appropriate validation data to show that the tests can perform accurately," the agency said. "This means there is a risk of potential false negative, false positive, and misinterpretation of results from these tests."
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 or Vivera Pharmaceuticals, or with the trade name EagleDx, the FDA said.
On Jan. 11, the FDA had posted a warning on its website cautioning against using LuSys Laboratories' COVID-19 antigen and antibody tests due to performance concerns.
On Jan. 13 and Jan. 24, LuSys sent Urgent Medical Device Recall letters to device customers, distributors, and other US consignees requesting them to immediately stop using the tests, the FDA said.
So far, 164,250 of LuSys' tests have been recalled in the US, the agency said, adding that the firm has received no complaints or reports of injuries, deaths, or adverse events.