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FDA warns against unauthorized COVID-19 rapid test

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(NEXSTAR) – The Food and Drug Administration has issued a Class I recall – the most serious type – and is warning consumers not to use a quick COVID-19 made by Skippack Medical Lab.

The test may cause false results, according to the FDA, and is “not cleared, authorized, or approved by the FDA for distribution or use in the United States.”

The FDA says Skippack never submitted adequate data showing that the tests, Skippack Medical Lab’s SARS-CoV-2 Antigen Rapid Tests (Colloidal Gold), worked properly.

On March 4, the Pennsylvania-based company issued a recall for more than 200,000 devices.

People who have used the swab tests should speak to a healthcare provider if they have any concerns about the results. The FDA is asking health care providers to consider issuing another test if they suspect a false negative or false positive test from Skippack Medical Lab within the past two weeks.

The FDA says it has not received any reports of test-related injuries or deaths.

If you believe there has been a problem with a SARS-CoV-2 test, the FDA encourages you to report the problem through the MedWatch voluntary reporting form.

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