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The Food and Drug Administration (FDA) informs the public that the following COVID-19 test kits distributed by the corresponding Market Authorization Holders (MAH) did not meet their declared product specificity and sensitivity after the performance validation conducted by the National Reference Laboratory- Research Institute of Tropical Medicine on COVID-19 Test Kits:

Product Name Classification Certificate No. Market Authorization Holder
Cellex qSARS-Cov-2 IgG/IgM Cassette Rapid Test Rapid/RTK SC-COVID-19-2020-114 Labx Corp.
SC-COVID-19-2020-130 Gepp Lab Solutions Inc
SC-COVID-19-2020-286 Allied Hospital Supply International Corporation
SC-COVID-19-2020-206 Labsolution Technologies, Inc
SC-COVID-19-2020-300 Phil. Pak Pharma Inc
QuickProfileTM COVID-19 Antigen Test Antigen SC-COVID-19-2020-627 Murex Diagnostic Products Specialists
Abbott Panbio™ COVID-19 lgG/lgM Rapid Test Device Rapid/RTK SC-COVID19-2020-177 Sunfu Solutions Inc
Innovita 2019-nCoV Antibody Test (Colloidal Gold) Rapid/RTK SC-COVID19-2020-037 Fas Diagnostic Group Inc
SC-COVID19-2020-133 Lifecore Bio Integrative Inc
SC-COVID19-2020-035 Sahar International Trading Inc
Camtech COVID-19 IgM/IgG          (CamTech-LFART)


Rapid/RTK SC-COVID19-2020-136 Keli Devices Distribution Inc
HighTop SARS-CoV-2 IgM/IgG             Antibody Rapid Test Rapid/RTK SC-COVID19-2020-082 Biotecnica Diagnostics Inc.
Diagnostic Kit for  IgM/IgG Antibody to Corona Virus (SARS-CoV-2) Colloidal Gold) -Livzon Rapid/RTK SC-COVID19-2020-184 Philippine Blue Cross Biotech Corporation
COVID-19 IgM/IgG Test Kit (Dry Fluorescence Immunoassay) (NL-CA002-2020-50668)- Lansion Biotechnology Rapid/RTK SC-COVID19-2020-316 Basemed Kare Inc.
SC-COVID19-2020-436 Labx Corporation
SC-COVID19-2020-408 Diamed Kinetics Healthcare On the Go
Standard™ Q COVID-19 Ag TEST Antigen SC-COVID19-2020-314 Worldwidelink Trading Corporation
SC-COVID19-2020-398 Trulaboratories Corporation
SC-COVID19-2020-445 H & B Pharma International Inc.
 Maglumi             2019-nCoV IgM (CLIA)


Maglumi              2019-nCoV IgG (CLIA)

Rapid/RTK SC-COVID19-2020-134



Labsolution Technologies, Inc.



Pharmastar Int’l Trading



Medasia Medical Products Corportion

In light of the foregoing, caution should be observed in the purchase and use of said test kits pending initiation of product recall proceedings.

For more information and inquiries, kindly contact the FDA Center for Device Regulation, Radiation Health, and Research through e-mail at [email protected], or call (02) 857-1900 loc. 8301.

Dissemination of this advisory to all concerned is hereby requested.

Attachment:-> FDA ADVISORY 2021-0450