November 25, 2020

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Health orders collection of more rapid tests of COVID-19 unauthorized by the FDA




The Secretary of Health Lorenzo González Feliciano ordered this Wednesday the collection of rapid tests for COVID-19 of the Clarity and Instant View brands, after the Federal Administration of Drugs and Food [19659003] (FDA) disallowed its use.

However, the official did not specify the amount of evidence they have to withdraw .

“The Department of Health has its inventory Clarity tests, so after the FDA's determination to remove these serological tests, the department was immediately ordered to collect them, since their use and distribution is prohibited . We are evaluating how much evidence we distribute and remain on the periphery to comply with the FDA order, "said González Feliciano through a press release.

He recognized that in Puerto Rico there may be evidence of these brands that have not been distributed by Health, reason why the private entities that acquired them must withdraw them immediately and inform the agency.

"Likewise, c any laboratory that has processed said tests, must contact the patient or authorized physician , and inform them of the possibility of erroneous results. Laboratories must make available to the patient the repetition of the tests, using a different test system, "stressed the official.

He indicated that the disavowal of the Testing by the FDA occurs in case the brands have not corrected a problem with the testing system or because they did not submit the necessary documentation on time. ia to grant an Emergency Use Permit (USA), among other reasons. He also added that the list of rapid tests authorized by the federal agency is constantly reviewed.

This is not the first time that Health has ordered the withdrawal of rapid tests, since in May it had to collect hundreds of serological tests that it purchased from the Castro Business company for the same reasons as now. At that time, González Feliciano also could not specify the amount of unauthorized evidence on the island.



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