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The National Health Surveillance Agency (Anvisa) decided Thursday (7) to ban a preventive component of the production of public laboratory Bahiafarma. The measure was taken after an inspection, with the participation of local health surveillance, in the company's health product line.
According to Anvisa, the ban is preventative and comes after the publication of a follow-up report from the National Institute for Health Quality Control (INCQS), which indicated that there was no such thing as a public health check. possible quality differences in diagnostic kits for dengue, zika and chikungunya.
The federal government has acquired approximately $ 120 million of product in 2016 and $ 160 million in 2017. The interim injunction prevents production in this part of society. However, tests already on the market will not be collected, according to Jota's website. Nor is there any prohibition in the field of drug manufacture.
PRIVILEGED TRIALS
The O Estado de S. Paulo newspaper revealed that the Bahiafarma rapid tests were frowned upon in the INCQS badyzes. Complaints were made regarding the effectiveness of the product in the states of Minas Gerais, São Paulo, Rio de Janeiro, Acre and Goiás and, because of the report indicating low sensitivity, the batches were collected for the purpose of 39, badysis
.
As a posting, Bahiafarma denied the failure of the INCQS tests. "The Institute's control badyzes, conducted in September 2018, resulted in the approval of rapid dengue tests, based on the parameters selected by the Ministry of Health, and highlighted nonconformities in many Chikungunya tests and many of the Zika test – the latter with the expiration date already expired, "says the text.
The Bahia laboratory also reported that Anvisa had requested a tax badysis of the tests, which will be performed by a laboratory accredited by the National Health Surveillance System (SNVS). "Although it has not received reports on the performance of control badyzes, as provided by the legal rite, Bahiafarma has determined that all necessary measures to prove the accuracy of his tests had been taken immediately, "adds the note [19659013 (f, f, f, f, f, f, f, f)
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