{"id":10346,"date":"2021-11-05T10:37:00","date_gmt":"2021-11-05T10:37:00","guid":{"rendered":"https:\/\/cvinoticias.com\/v3\/?p=10346"},"modified":"2021-11-05T10:39:24","modified_gmt":"2021-11-05T10:39:24","slug":"10346-2","status":"publish","type":"post","link":"https:\/\/cvinoticias.com\/v3\/10346-2\/","title":{"rendered":"La Anmat prohibi\u00f3 el uso, la comercializaci\u00f3n y distribuci\u00f3n de un test r\u00e1pido de Covid"},"content":{"rendered":"\n<p><strong><em>La\u00a0Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda M\u00e9dica\u00a0(Anmat) prohibi\u00f3 este viernes el\u00a0uso, la comercializaci\u00f3n y la distribuci\u00f3n\u00a0en todo el territorio argentino de un\u00a0test r\u00e1pido de\u00a0coronavirus\u00a0importado desde China. Del mismo modo, el organismo regulador lanz\u00f3 resoluciones similares a una serie de productos m\u00e9dicos y un aceite.<\/em><\/strong><\/p>\n\n\n\n<p>A trav\u00e9s de la\u00a0Disposici\u00f3n 8209\/2021\u00a0publicada en el Bolet\u00edn Oficial, la ANMAT prohibi\u00f3 el uso, comercializaci\u00f3n y distribuci\u00f3n del\u00a0 \u201ctest r\u00e1pido Covid-19 IgG\/IgM (incluye soluci\u00f3n Bufer), fabricado por Hangzhou Immuno Biotech Co Ltd., China. Director T\u00e9cnico: Farm. Natalia Vanina Panzero M.N. 16.281\/202006t02 \/ Autorizado por el Anmat; M.S. Y A.S. \/ X Unidad\u201d.<\/p>\n\n\n\n<p>Seg\u00fan explicaron en los considerandos del texto oficial, la medida surgi\u00f3 a partir de una denuncia contra el producto chuino \u201cel cual no cuenta con datos de registro, importador, lote y vencimiento entre otra informaci\u00f3n\u201d. Por lo tanto, se\u00f1alaron que que se trata de un art\u00edculo \u201cfalsificado\u201d del que\u00a0 \u201cse desconoce su efectivo origen y composici\u00f3n, situaci\u00f3n que resulta en un riesgo para la salud de quienes pudieran utilizarlo con fines diagn\u00f3sticos\u201d.<\/p>\n\n\n\n<p>Asimismo, respecto a los detalles del procedimiento precisaron que, \u201centre las diferencias que se pudieron apreciar, la unidad original se distribuye en presentaci\u00f3n por 20 unidades, que incluyen 20 pouch con la tira reactiva, un frasco buffer para ser utilizado con las 20 tiras reactivas y 20 pipetas y posee un instructivo de uso; mientras que la muestra falsificada se encuentra usada, no posee buffer, pipeta ni pouch\u201d.<\/p>\n\n\n\n<p>Por otro lado, remarcaron que \u201cla unidad original posee un r\u00f3tulo sobre el estuche secundario con toda la informaci\u00f3n requerida (datos del importador, director t\u00e9cnico, fabricante, lote, vencimiento etc.), mientras que la unidad falsificada no cuenta con datos de importador, lote ni vencimiento\u201d. \u201cRespecto al instructivo de uso, el original posee indicaciones en ambas caras, mientras que el instructivo falsificado es una copia del original impreso en una sola cara con la informaci\u00f3n incompleta\u201d, agregaron.\u00a0<\/p>\n\n\n\n<p>Por otro lado, a trav\u00e9s de la Disposici\u00f3n 8212\/2021 se prohibi\u00f3 el uso, comercializaci\u00f3n y distribuci\u00f3n de los siguientes productos m\u00e9dicos: electrodo para estimulaci\u00f3n endoc\u00e1rdica (Tendril STS, Lote P000093003, Serie n\u00b0 CPA833412); electrodo para estimulaci\u00f3n endoc\u00e1rdica (Tendril STS, Lote A000107077, Serie n\u00b0 CAW360540); introductor de cat\u00e9ter (Peel Away Lote 7737533, serie n\u00b0 SJ00025160); introductor de cat\u00e9ter (Peel Away Lote 7737533, serie n\u00b0 SJ00024989); marcapasos cardiaco implantable (Endurity Core Lote P000106971, serie n\u00b0 9748686).<\/p>\n\n\n\n<p>En tanto, mediante la Disposici\u00f3n 8213\/2021, la Anmat prohibi\u00f3 un aceite de girasol \u201cmarca \u00d3leos, RNE N\u00b0 02-032427, RNPA N\u00b0 21-02504972\u201d al definir que el art\u00edculo \u201ccarece de autorizaci\u00f3n de establecimiento y de producto, y est\u00e1 falsamente rotulado\u201d.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>La\u00a0Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda M\u00e9dica\u00a0(Anmat) prohibi\u00f3 este viernes el\u00a0uso, la comercializaci\u00f3n y la distribuci\u00f3n\u00a0en todo el territorio argentino de un\u00a0test r\u00e1pido de\u00a0coronavirus\u00a0importado desde China. Del mismo modo, el organismo regulador lanz\u00f3 resoluciones similares a una serie de productos m\u00e9dicos y un aceite. A trav\u00e9s de la\u00a0Disposici\u00f3n 8209\/2021\u00a0publicada en el Bolet\u00edn Oficial, la [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":10347,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[35],"tags":[],"class_list":["post-10346","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-informacion-general"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>La Anmat prohibi\u00f3 el uso, la comercializaci\u00f3n y distribuci\u00f3n de un test r\u00e1pido de Covid | CVI NOTICIAS<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/cvinoticias.com\/v3\/10346-2\/\" \/>\n<meta property=\"og:locale\" content=\"es_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"La Anmat prohibi\u00f3 el uso, la comercializaci\u00f3n y distribuci\u00f3n de un test r\u00e1pido de Covid | CVI NOTICIAS\" \/>\n<meta property=\"og:description\" content=\"La\u00a0Administraci\u00f3n Nacional de Medicamentos, Alimentos y Tecnolog\u00eda M\u00e9dica\u00a0(Anmat) prohibi\u00f3 este viernes el\u00a0uso, la comercializaci\u00f3n y la distribuci\u00f3n\u00a0en todo el territorio argentino de un\u00a0test r\u00e1pido de\u00a0coronavirus\u00a0importado desde China. 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