The Food and Drug Administration (FDA) informs all concerned healthcare professionals and the general public on the recall of the following COVID-19 test kits distributed by the corresponding Market Authorization Holders (MAHs) which did not meet their declared product specificity and sensitivity after the low results of performance validation conducted by the RITM on the said in vitro diagnostic test kits:
Market Authorization Holder
|1||Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test||SC-COVID19-2020-286||Allied Hospital Supply
|2||Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test||SC-COVID19-2020-206||Labsolution Technologies, Inc.|
|3||Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid Test||SC-COVID19-2020-300||Phil. Pak Pharma Inc.|
|4||Innovita 2019-nCoV Antibody Test (Colloidal Gold)||SC-COVID19-2020-037||Fas Diagnostic Group Inc.|
|5||Innovita 2019-nCoV Antibody Test (Colloidal Gold)||SC-COVID19-2020-133||Lifecore Bio Integrative Inc.|
|6||Innovita 2019-nCoV Antibody Test (Colloidal Gold)||SC-COVID19-2020-035||Sahar International Trading Inc.|
|7||Diagnostic Kit for IgM/IgG Antibody to Coronavirus
(SARS-CoV-2 Colloidal Gold)
|SC-COVID19-2020-184||Philippine Blue Cross Biotech Corporation|
|8||COVID-19 IgM/IgG Test Kit
(Dry Fluorescence Immunoassay)
|SC-COVID19-2020-408||Diamed Kinetics Healthcare On The Go|
|9||Standard™ Q COVID-19 Ag Test||SC-COVID19-2020-445||H&B Pharma International Inc.|
|10||SARS-CoV-2 Antibody Test (Colloidal Gold Immunochromatography)
-Beijing Lepu Medical Technology
|11||COVID-19 IgM Antibody Rapid Test Kit-Hecin Scientific, Inc.||SC-COVID19-2020-225||Bastion Payment Systems Corporation|
The above-mentioned MAHs were notified by the FDA and were given ample time to explain in writing about the non-conformance of their product to the declared specifications. However, this Office did not receive any response from the said companies resulting to this recall.
Further, in compliance to FDA Memorandum No. 2021-009, all other MAHs, particularly with the same product as listed above, who have not submitted their documents for performance validation conducted by RITM are reminded to comply with prescribed period of thirty (30) days from the date of notice of submission from FDA to avoid revocation of issued special certification.
In light of the foregoing, all concerned healthcare professionals, establishments, and the general public are warned to discontinue further use, sale, and distribution of the identified COVID-19 test kits.
All FDA Regional Field Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and Local Government Units, are requested to ensure that these products are not sold or made available in the market or areas of jurisdiction.
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) 8857-1900 loc. 8301.
Dissemination of this advisory to all concerned is hereby requested.