The recall has been identified by the FDA as a Class I recall, the “most serious type of recall” because “the use of these tests may lead to serious adverse health consequences or death.” The FDA stated that false positives may lead to delays in the diagnosis or treatment of a person’s disease The actual reason for this; acceptance of unnecessary Covid-19 treatment that may have side effects; and disregard of preventive measures against Covid-19, including vaccination.
The FDA stated that there have been 35 false positive reports and no death reports. The agency said that the reliability of negative test results will not be affected.
Tests produced from February 24 to August 11 and distributed from April 13 to August 26 are included in the recall.
“The FDA will continue to work with Ellume to evaluate the company’s corrective actions, such as additional manufacturing inspections and other corrective steps, to address the cause of manufacturing problems and help ensure that the problems are resolved and do not recur,” the agency said on Wednesday.
Ellume requires that the affected products be removed from the shelves and not sold; it recommends that those who get a positive result in a test undergo follow-up tests to confirm their diagnosis.
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