TEN coronavirus disease (COVID-19) testing kits are facing possible recall from the Food and Drug Administration (FDA) after failing to meet their declared capability to detect the deadly virus.
In Advisory No. 2021-0450, the FDA said it is looking into the possibility of issuing recall orders for 10 rapid and antigen COVID-19 testing kits previously issued marketing authorizations.
The 10 test kits are Cellex qSARS-Cov-2 IgG/IgM Cassette Rapid Test, QuickProfileTM COVID-19 Antigen Test, Abbott Panbio™ COVID-19 lgG/lgM Rapid Test Device, Innovita 2019-nCoV Antibody Test (Colloidal Gold), Camtech COVID-19 IgM/IgG (CamTech-LFART), HighTop SARS-CoV-2 IgM/IgG Antibody Rapid Test, Diagnostic Kit for IgM/IgG Antibody to Corona Virus (SARS-CoV-2) Colloidal Gold) -Livzon, COVID-19 IgM/IgG Test Kit (Dry Fluorescence Immunoassay) (NL-CA002-2020-50668)- Lansion Biotechnology, Standard™ Q COVID-19 Ag TEST, and Maglumi 2019-nCoV IgM (CLIA).
The FDA said “caution should be observed in the purchase and use of said test kits pending initiation of product recall proceedings.”
In a separate statement, FDA Director General Eric Domingo said two more COVID-19 rapid test kits, outside of the 10, may face a similar fate.