La ANMAT prohibió un test de covid, un aceite de girasol y productos médicos

La ANMAT prohibió el “uso, comercialización y distribución en todo el territorio nacional de las unidades ilegítimas” de la prueba de coronavirus fabricada por la empresa Hangzhou Immuno Biotech CO LTD., con sede en China, bajo la dirección técnica de Natalia Vanina Panzero, cuya Matrícula Nacional es 16.281/202006T02.

El producto fue detectado a partir de una denuncia realizada por el presidente de la Cámara Argentina de Reactivos para Diagnóstico (CAPRODI) a raíz de que uno de estos productos no contaba “con datos de registro, importador, lote y vencimiento, entre otras información”.

El test había sido adquirido en una farmacia de la provincia de Santa Fe. El mismo fue entregado después a las autoridades de la ANMAT para la “posterior verificación de legitimidad”.

La Anmat pudo comprobar que el producto era falsificado y que tenía varias diferencias con respecto al original. “Entre las diferencias que se pudieron apreciar, la unidad original se distribuye en presentación por veinte unidades, que incluyen veinte pouch con la tira reactiva, un frasco buffer para ser utilizado con las veinte tiras reactivas y veinte pipetas y posee un instructivo de uso; mientras que la muestra falsificada se encuentra usada, no posee buffer, pipeta ni pouch”, se precisó en la Disposición 8209/2021.

Las autoridades detallaron que el test verdadero “posee un rótulo sobre el estuche secundario con toda la información requerida (datos del importador, director técnico, fabricante, lote, vencimiento etc.)”, pero, en cambio, la copia ilegal no cuenta con nada de eso, además de tener mal el número de la matrícula de la directora técnica Natalia Panzero.

Productos médicos prohibidos

En segundo lugar, la Anmat retiró del mercado algunos aparatos médicos de diferentes empresas. Lo hizo a través de la Disposición 8212/2021.

Uno de estos es el electrodo para la estimulación endocárdica de la marca Tendril STS. Puntualmente, los lotes afectados son los P000093003, Serie n° CPA833412; y A000107077, Serie n° CAW360540.

Lo mismo hizo con un introductor de catéter de la firma Peel Away, lotes 7737533, serie n° SJ00025160, y 7737533, serie n° SJ00024989; y un marcapasos cardíaco implantable de la compañía Endurity Core, lote P000106971, serie n° 9748686.

En el informe se detalló que todos estos elementos se encontraban aprobados por la ANMAT, identificados únicamente mediante un número de serie e incorporados en el Sistema Nacional de Trazabilidad, por lo que consten en el sistema como productos “robados”.

“En consecuencia, y a fin de proteger a eventuales adquirentes y usuarios de los productos involucrados, la Dirección de Evaluación y Gestión de Monitoreo de productos para la Salud sugirió prohibir el uso, comercialización y distribución en todo el territorio nacional de los productos identificados”, señaló el documento.

Aceite sin autorización

El organismo también prohibió el “Aceite de girasol, marca Óleos, RNE N° 02-032427, RNPA N° 21-02504972″ por carecer de autorización de establecimiento y de producto, y estar falsamente rotulado al consignar en su rótulo un número de RNE que se encuentra vencido y de RNPA inexistente, resultando ser un producto en consecuencia ilegal.

En la Disposición 8213/2021, se informó que esta decisión se tomó a raíz de una denuncia realizada ante el Instituto de Control de Alimentación y Bromatología (ICAB) de la provincia de Entre Ríos en relación a la comercialización de este alimento.

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