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FDA recalls COVID-19 Test Kits

FDA recalls COVID-19 Test Kits due to low-performance results

QUEZON CITY (PIA) -- The Food and Drug Administration (FDA) on Monday, August 9, ordered the recall of several COVID-19 test kits from the market, which did not meet product specificity and sensitivity after low results of performance validation by the Research Institute of Tropical Medicine (RITM).

FDA warned all concerned healthcare professionals, establishments, and the general public to discontinue further use, sale, and distribution of the following recalled COVID-19 test kits.

Product NameMarket Authorization Holder
Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid TestAllied Hospital Supply International Corporation
Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid TestLabsolution Technologies, Inc.
Cellex qSARS-CoV-2 IgG/IgM Cassette Rapid TestPhil. Pak Pharma Inc.
Innovita 2019-nCov Antibody Test (Colloidal Gold)Fas Diagnostic Group Inc.
Innovita 2019-nCov Antibody Test (Colloidal Gold)Lifecore Bio Integrative Inc.
Innovita 2019-nCov Antibody Test (Colloidal Gold)Sahar International Trading Inc.
Diagnostic Kit for IgM/IgG Antibody to Coronavirus (SARS-CoV-2 Colloidal Gold) – LIVZONPhilippine Blue Cross Biotech Corporation
COVID-19 IgM/IgG Test Kit (Dry Fluorescence Immunoassay) (NL-CA002-2020-50668) – Lansion BiotechnologyDiamed Kinetics Healthcare On The Go
Standard TM Q COVID-19 Ag TestH&B Pharma International Inc.
SARS-CoV-2 Antibody Test (Colloidal Gold Immunichromatography) – Beijing Lepu Medical TechnologyEmperial Trading
COVID-19 IgM Antibody Rapid Test Kit-Hecin Scientific, Inc.Bastion Payment Systems Corporation

FDA notified the Market Authorization Holders (MAHs) but did not receive any explanation for non-conformance from the said companies, which results in this recall.

All FDA Regional Offices and Regulatory Enforcement Units, in coordination with law enforcement agencies and LGU, are requested to ensure that these products are not distributed 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 or call (02) 8857-1900 local 8301. (MCDS/PIA-IDPD with information from FDA)

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Mary Rose delos Santos


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