This week, two companies announced Class I recalls, the most serious kind, for COVID-19 antigen and antibody tests that have reached the US market without FDA Emergency Use Authorization (EUA) or 510(k) clearance.
San Diego-based LuSys Laboratories is recalling COVID-19 Antigen Test (Nasal/Saliva) and COVID-19 IgG/IgM Antibody Test, after it failed “to provide appropriate validation data” for the products, an FDA statement noted. Nearly 165,000 of the tests have been recalled so far, according to the FDA, which also slapped LuSys with a warning letter for marketing the tests without authorization.
Meanwhile, Celltrion initiated Class I recalls for the Celltrion DiaTrust COVID-19 Ag Rapid Test, an antigen test erroneously released to customers without FDA authorization, and a research-use only version of the kit distributed to customers unlikely to use them for research purposes.
This isn’t the first time that Celltrion has gotten into hot water with the FDA over unauthorized COVID-19 tests this year. In February, the South Korean firm recalled 162,000 tests that were slated for Europe but somehow wound up in the US instead.