FDA warns against using unauthorized COVID-19 rapid test

(NEXSTAR) — The Food and Drug Administration (FDA) has issued a Class I recall — probably the most severe kind — and is caution shoppers to not use a speedy COVID-19 manufactured by means of Skippack Medical Lab.

The check would possibly lead to false effects, the FDA says, and is “not authorized, cleared, or approved by the FDA for distribution or use in the United States.”

The FDA says Skippack by no means submitted good enough knowledge appearing the exams, the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tests (Colloidal Gold), labored correctly.

On March 4, the Pennsylvania-based corporate issued a recall for over 200,000 of the units.

People who used the swab-based exams will have to communicate to a healthcare supplier if they have got considerations about effects. The FDA is looking healthcare suppliers to believe issuing some other check if they believe a false-negative or false-positive check from Skippack Medical Lab throughout the closing two weeks.

The FDA says they have got now not won any experiences of accidents or dying tied to the exams.

If you watched there was once an issue with a SARS-CoV-2 check, the FDA encourages you to record the issue during the MedWatch Voluntary Reporting Form.

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