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FDA's MedWatch Adverse Event Reporting

COVID-19: Recall Issued For Brand Of Rapid Tests That Could Produce Inaccurate Results COVID-19: Recall Issued For Brand Of Rapid Tests That Could Produce Inaccurate Results
Covid-19: Recall Issued For Brand Of Rapid Tests That Could Produce Inaccurate Results A manufacturer has recalled more than 56,000 COVID-19 rapid tests because they could produce inaccurate results. Universal Meditech Inc. issued the recall for Skippack Medical Lab antigen tests because they were distributed without appropriate clearance or approval by the US Food and Drug Administration (FDA). The kits were made from October 2021 to December 2021 and distributed in January 2022. The following styles/models have been recalled: Name of Product: Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kit UDI: None Model: Cassette Products were distributed with “Sk…