The US Food and Drug Administration has issued “the most serious type of recall” for popular home testing kits that show if one is infected with the coronavirus. As a result, at least 2.2 million products may have been showing false positives.
The public health agency said that some 2,212,335 kits produced by the Australian-based biotech company Ellume and distributed in the US potentially show false positive SARS-CoV-2 test results in a statement on Thursday.
The FDA warned that the use of faulty kits “may cause serious adverse health consequences or death,” identifying the case as a ‘Class I recall.’
The antigen test, which detects coronavirus proteins, was authorized for emergency use by the FDA last year. It is available without a prescription for both adults and children aged two and older and uses swab samples taken from a nose to detect if one has Covid. Some “specific lots” manufactured between February and August this year are now being recalled in the US. The company says it has worked with the authorities to remove the affected tests from the market voluntarily. The company has offered its apologies “for any stress or difficulties [customers] may have experienced because of a false-positive result.”
The “higher-than-acceptable” false results, showing that a person has coronavirus when they do not, have been reported to the FDA in at least 35 cases. No false-negative results have been detected. However, the inaccurate diagnostic could have life-threatening consequences. For example, a person might receive wrong or unnecessary treatment, including antiviral and antibody therapy, and suffer additional trauma over being isolated from family members and friends. The FDA has said that it might also lead to people disregarding precautions, including getting vaccinated against Covid-19.
News Staff
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