The U.S. Food and Drug Administration characterized the recall as a Class 1, the most serious type issued.
, there have been no reports to date of adverse health consequences or deaths linked to use of the affected tests, but the FDA is “concerned about the potential high risk of false results when using unauthorized tests.”People who were tested using these medical devices
Health care providers who may have access to and use these tests or whose patients have used these tests Organizers of large testing programs, such as in the workplace or schools, who may be using and distributing these tests for diagnostic use
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