FDA slaps LuSys Labs with Class I label for recall of antibody, antigen COVID tests

Well, that escalated quickly. Two months after the FDA issued a safety warning advising the public to stop using LuSys Laboratories’ unauthorized antigen and antibody COVID-19 tests, the company has initiated a formal recall of the tests that was branded this week with the FDA’s most serious rating.

The Class I recall covers LuSys’ antigen test kits for both saliva and nasal samples, as well as the blood-based antibody test. None of the tests have been authorized by the FDA and, furthermore, according to the agency, the company never even submitted applications for authorization before distribution began.

Customers and distributors have already received notice of the recall and are advised to immediately stop using and discard, destroy or return all affected tests.

In the recall notice, the FDA said that because LuSys has not provided documentation of its tests’ accuracy, “there is a risk of potential false negative, false positive and misinterpretation of results from these tests.”

Any of those false or misinterpreted results could, in turn, lead to the unnecessary spread of the coronavirus—if a test-taker incorrectly believes themselves to be COVID-free or have antibody immunity—and so the FDA has recommended that anyone who used a LuSys diagnostic in recent weeks should be re-tested.

So far, the San Diego-based company hasn’t received any complaints about the issue nor any reports of injury or death linked to the unauthorized tests.

The recall comprises a total of 164,250 tests distributed in the U.S. between June 2020 and July 2021. According to the FDA, the kits have also been sold outside the U.S., in Canada, China and Mexico. They were distributed under a host of names in addition to LuSys, including Luscient Diagnostics, Vivera Pharmaceuticals and EagleDx.

This month the FDA has cracked down on unauthorized COVID tests and treatments that have found their way to market.

In quick succession in early March, it issued a trio of safety notices warning against the use of unauthorized test kits from ACON Laboratories, SD Biosensor and Celltrion. In this case, though each of the companies has received the agency’s OK for one or more of their COVID offerings, other unauthorized kits from their stockpiles were found to be circulating throughout the U.S. as well.

The testmakers pointed toward either illegal import practices as the culprit behind the safety issue or, in ACON’s case, to sales of an “unauthorized, adulterated and misbranded counterfeit product,” and all have initiated recalls of their own.