La Agencia Federal de Drogas y Alimentos (FDA, por sus siglas en inglés), publicó una lista de pruebas rápidas para detectar el COVID-19 que están desautorizadas bajo la política de pruebas de la enfermedad durante la emergencia provocada por la pandemia.
A través de su portal, la agencia federal puntualizó que las pruebas mencionadas en esta lista no deben ser comercializadas ni distribuidas.
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“La acción tomada hoy es un paso importante que nuestra agencia ha tomado para asegurar que los ciudadanos americanos tengan acceso a pruebas confiables”, expresó el comisionado de la FDA, Stephen M. Hahn, M.D.
La FDA indicó que esta lista se seguirá actualizando.
En la lista de pruebas se menciona a la marca Promedical, empresa a la cual Apex General Contractor le compraría un millón de pruebas rápidas para detectar Covid-19 y venderla al gobierno de Puerto Rico, en una fallida transacción que generó críticas al manejo de la crisis por parte de la administración de Wanda Vázquez y provocó el inicio de una pesquisa cameral.
En la lista también aparece Phamatec, por lo que el Departamento de Salud de Puerto Rico distribuyó y luego de la notificación ordenó su recogido.
A continuación la lista de “pruebas rápidas” que la FDA indica que no deben ser distribuidas:
| Anhui Deepblue Medical Technology Co., Ltd. | COVID-19 (SARS-CoV-2) IgG/IgM Antibody Test Kit (Colloidal Gold) | Removed – Should Not Be Distributed |
| Artron BioResearch Inc./ Artron Laboratories Inc. | COVID-19 IgM/IgG Antibody Test | Removed – Should Not Be Distributed* |
| BestNovo (Jiangsu) Medical Technology Co., Ltd. | BestNovo COVID-19 IgM/IgG Antibody Rapid Test Kit | Removed – Should Not Be Distributed |
| Biobase Biodustry (Shandong) Co., Ltd. | SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold) | Removed – Should Not Be Distributed |
| BioMedomics, Inc. | COVID-19 IgM-IgG rapid test | Removed – Should Not Be Distributed* |
| Bioscience(Chongqing) Diagnostic Technology Co., Ltd. | Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgM Antibody | Removed – Should Not Be Distributed |
| Bioscience(Chongqing) Diagnostic Technology Co., Ltd. | Qualitative Diagnostic Kit for Novel Coronavirus (2019-nCoV) IgG Antibody | Removed – Should Not Be Distributed |
| Bioscience(Tianjin) Diagnostic Technology Co., Ltd. | Qualitative Diagnostic Kit for Novel Coronavirus(2019-nCoV) IgM Antibody | Removed – Should Not Be Distributed |
| Bioscience(Tianjin) Diagnostic Technology Co., Ltd. | Qualitative Diagnostic Kit for Novel Coronavirus(2019-nCoV) IgG Antibody | Removed – Should Not Be Distributed |
| Boson Biotech Ltd. Co (Distributed by Pure Genetic Medical Ltd.) | Rapid 2019-nCoV IgG/IgM Combo Test Card | Removed – Should Not Be Distributed |
| Changchun Wancheng Bio-Electron Co., Ltd. | COVID-19 IgG/IgM ANTIBODY RAPID TEST KIT (Colloidal gold immunochromatography) | Removed – Should Not Be Distributed |
| Diazyme Laboratories, Inc. | Diazyme SARS-CoV-2 Antibody Rapid Test | Removed – Should Not Be Distributed* |
| Genlantis Diagnostics, Inc. | CovidQuik Coronavirus (COVID-19) IgM/IgG Antibody Test | Removed – Should Not Be Distributed* |
| Hangzhou Clongene Biotech Co., Ltd. | COMBRA COVID-19 IgM/IgG Rapid Test Cassette | Removed – Should Not Be Distributed |
| Hangzhou Testsea Biotechnology Co., Ltd. | One Step SARS-CoV2(COVID-19) IgG/IgM Test | Removed – Should Not Be Distributed* |
| Hunan RunKun Pharmaceutical Co., Ltd. | SARS-CoV-2 lgM/lgG Test Kit (Colloidal Gold) | Removed – Should Not Be Distributed* |
| IMMY, Inc. | clarus SARS-CoV-2 Total Antibody EIA | Removed – Should Not Be Distributed* |
| Jiangsu Eubo Biotechnology Co., Ltd. | EUBO COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P) | Removed – Should Not Be Distributed |
| Lifeassay | Test-it COVID-19 IgM/IgG Lateral Flow Assay | Removed – Should Not Be Distributed |
| Phamatech | COVID19 IgG / IgM Rapid Test | Removed – Should Not Be Distributed* |
| Promedical | COVID-19 Rapid Test | Removed – Should Not Be Distributed |
| Saladax Biomedical | COVID-19 IgG/IgM Rapid Antibody Test | Removed – Should Not Be Distributed* |
| Shanghai Eugene Biotech Co., Ltd. | SARS-CoV2 (COVID-19) IgG/IgM Rapid Test | Removed – Should Not Be Distributed |
| Shenzen Landwind Medical Co., Ltd. | COVID-19 IgG/IgM Rapid Test | Removed – Should Not Be Distributed* |
| VITA Testing | COVID-19 IgM/IgG Antibody Rapid Test Kit | Removed – Should Not Be Distributed |
| Zhengzhou Fortune Bioscience Co., Ltd. | COVID-19 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography Method) | Removed – Should Not Be Distributed |
| Zhengzhou Fortune Bioscience Co., Ltd. | COVID-19 IgM Antibody Rapid Test Kit | Removed – Should Not Be Distributed |
| Zhengzhou Fortune Bioscience Co., Ltd. | COVID-19 IgG Antibody Rapid Test Kit | Removed – Should Not Be Distributed |
| Zhongshan Bio-Tech Co Ltd. | SARS-CoV-2 IgM/IgG (GICA) | Removed – Should Not Be Distributed* |
