Scorecard: COVID-19 Rapid Test Recalls and Warnings in 2022
Not even two full months into 2022, the U.S. Food and Drug Administration (FDA) has issued Safety Communications for three different COVID-19 tests, only one fewer than it issued for all of 2021. Here is a rundown of the latest recalls and warnings. The LuSys Laboratories Rapid Tests Warning On Jan. 11, the agency posted a Safety Communication warning against the use of two tests from LuSys Laboratories that have not received regulatory clearance: the LuSys Laboratories COVID-19 Antigen Test (Nasal/Saliva) and LuSys Laboratories COVID-19 IgG/IgM Antibody Tests. The tests have also been sold under the names Luscient Diagnostics or Vivera Pharmaceuticals, or with the trade name EagleDx, for use in laboratories or at-home testing, according to the agency. The tests are not “adequately established” and pose a high risk of both false negatives and false positives. Users who have been tested with either assay should talk to their health care providers while providers that offered the antigen test less than two weeks ago or the antibody test at any time should consider retesting their patients. The Empowered Diagnostics Warning & Recall On Jan. 28, the FDA issued a “do not use” warning for a pair of rapid COVID-19 tests […]

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