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The FDA cited reports of “endcap separation, O-ring seal failure and potential exposure of internal components of this device to living tissue that may lead to adverse local tissue reactions” in Magec devices. Read More
The warning letter is among a recent spate of letters by the agency aimed at stopping the marketing of unauthorized products related to the COVID-19 pandemic. Read More
Unapproved COVID-19 tests are especially risky because “a lay person [may not have] the ability to collect their specimen, run the test and interpret the test result accurately,” the agency said. Read More