The Food and Drug Administration (FDA) informs all healthcare professionals and the general 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 for Tropical Medicine on COVID-19 Test Kits:
|
Product Name |
Classification | Cert No. |
Market Authorization Holder |
| Novel Coronavirus (2019nCoV) IgG/IgM Test Kit (Colloidal Gold)
Mfd by: Genrui Biotech Inc. |
RAPID/ RTK |
SC-COVID19-2020-414 |
RTS Express Import and Export |
| GenBody COVID-19 IgG/IgM RAPID DIAGNOSTIC TEST Mfd by: Genrui Biotech Inc. |
RAPID/ RTK |
SC-COVID19-2020-654 |
UC Biosciences Inc. |
|
SC-COVID19-2020-292 |
Creative Bakers Company Inc. |
||
| COVID-19 (SARS-CoV-2) IgM/IgG Antibody Test Kit Mfd by: Wuhan EasyDiagnosis Biomedicine Co. Ltd. |
RAPID/ RTK |
SC-COVID19-2020-487 |
Babyzone Philippines, Inc. |
| ChekR™ COVID-19 IgM/IgG Rapid Test Kit Mfd by: B-bio, Co. Ltd. |
RAPID/ RTK |
SC-COVID19-2020-516 |
Medimax Corporation |
| SARS-CoV-2 IgG/IgM Kit Mfd by: Goldsite Diagnostics Inc. |
RAPID/ RTK |
SC-COVID19-2020-442 |
Labsolution Technologies, Inc. |
|
SC-COVID19-2020-608 |
TwinJ3 Sales and Marketing Corporation
|
||
| FaStep COVID-19 Antigen Rapid Test Device (Nasopharyngeal/ Oropharyngeal Swab)
Mfd by: Assure Tech (Hangzhou) Co. Ltd. |
ANTIGEN |
SC-COVID19-2020-583 |
Sahar International Trading, Inc. |
In light of the foregoing, caution should be observed in the purchase and use of the 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.