FILE – This Aug. 2, 2018, file photo shows the U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency’s campus in Silver Spring, Md. U.S. regulators have approved a new type of coronavirus test that administration officials have touted as a key to opening up the country. The Food and Drug Administration on Saturday, May 9, 2020, announced emergency authorization for antigen tests developed by Quidel Corp. of San Diego. The test can rapidly detect fragments of virus proteins in samples collected from swabs inside the nasal cavity, the FDA said in a statement. (AP Photo/Jacquelyn Martin, File)
(NEXSTAR) – The Food and Drug Administration has issued a Class I recall – the most serious type – and is warning consumers not to use a rapid COVID-19 manufactured by Skippack Medical Lab.
The test may result in false results, 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 never submitted adequate data showing the tests, the Skippack Medical Lab SARS-CoV-2 Antigen Rapid Tests (Colloidal Gold), worked properly.
On March 4, the Pennsylvania-based company issued a recall for over 200,000 of the devices.
People who used the swab-based tests should talk to a healthcare provider if they have concerns about results. The FDA is asking healthcare providers to consider issuing another test if they suspect a false-negative or false-positive test from Skippack Medical Lab within the last two weeks.
The FDA says they have not received any reports of injuries or death tied to the tests.
If you suspect there was a problem with a SARS-CoV-2 test, the FDA encourages you to report the problem through the MedWatch Voluntary Reporting Form.
