December 1, 2020

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Health orders to withdraw rapid tests for coronavirus Clarity and Instant View


The secretary of the Department of Health, Lorenzo González Feliciano, reported that as a result of the notification from the Food and Drug Administration (FDA), the collection of serological (rapid) tests of the marks Clarity and Instant View.

"The Health Department has in its inventory Clarity tests, so after the determination of the FDA to remove these serological tests, the collection of them by the department was ordered immediately, since its 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 in written statements.

The Laboratory Division, attached to the Auxiliary Secretariat for Regulation and Accreditation of Health Facilities (SARAFS ), explained that there may be tests not distributed by the Department of Health, so private entities must coordinate their collection.

Likewise, any laboratory that has processed said tests must contact the patient or licensed physician, and inform you of the possibility of erroneous results. Laboratories must make repeat testing available to the patient, using a different testing system

The agency noted that FDA's disavowal of testing may be substantiated for a number of reasons, including failure to correct some problem with the test system or not having submitted in time the necessary documentation to grant an Emergency Use Permit (USA), among other reasons.

The list of serological tests that have FDA authorization is reviewed constantly, so Salud remains attentive to the guidelines established to make decisions regarding the administration of the acquired tests, the agency mentioned.

Entities that have received Clarity tests from Salud can notify them through the mail electronic [email protected].



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