FDA said that it was particularly concerned about false-negative results, in which an infected person is told by the test that they don’t have the disease. TOKYO/NEW YORK : An Abbott Laboratories Covid-19 test has potential accuracy issues, the U.S.
Food and Drug Administration warned, citing a number of studies that have raised doubts about the product’s precision when used to quickly diagnose patients.
The FDA issued a public alert Thursday evening, saying that it had become aware of several scientific studies that raised questions about the device, a printer-sized machine called ID Now that can take a sample from a nasal swab and diagnose a coronavirus infection in less than 15 minutes.