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
SC-COVID19-2020-135 |
Labsolution Technologies, Inc. |
| SC-COVID19-2020-153
SC-COVID19-2020-152 |
Pharmastar Int’l Trading | ||
| SC-COVID19-2020-306
SC-COVID19-2020-307 |
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