February 14, 2023

FDA: Class I recall of Skippack Medical Lab COVID-19 tests

By: Judy Mathias

Editor's Note

The Food and Drug Administration (FDA) on February 8 identified the recall by Universal Meditech Inc of its Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test (Colloidal Gold) as Class I, the most serious.

The recall was initiated because the tests were distributed to US customers without authorization, clearance, or approval from the FDA.

Distribution dates were January 2022.


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