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FDA Slaps High Risk Class I Label On Recall Of COVID-19 Diagnostics Made In Uncontrolled Plant

 
• By Shawn M. Schmitt

More than 160,000 of the tests were recalled, including 104,900 COVID Test Kits Nonsterile and 61,500 Clean Catch Urine Kits.

Recall Road Sign against sky.
• Source: Shutterstock

A recall of hundreds of thousands of test kits used to detect SARS-CoV-2 has been given the US Food and Drug Administration’s highest risk designation.

The class I recall by American Contract Systems of its diagnostics was initiated by the company on 1 May. More...

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