The US Food and Drug Administration sent back “the more serious kind” of call back for a famous home test kit that found that Self one had the coronavirus. At least 2.2 million items might have been seen as fake positives.
The public health agency said in a statement on Thursday that about 2,212,335 kits made by the Australian biotech company Ellume and sold in the US might give fake positive SARS-CoV-2 test results.
The FDA has warned that using broken kits “may cause major adverse health consequences or death.” This is known as the “Class I remember” case.
The FDA approved the antigen test last year for use in emergencies. It finds proteins that are part of the coronavirus. And it can be used to check for covid without a prescription on people and children aged two years and up. A swab sample is taken from the nose. Some “specific batches” made between February and August of this year are being recalled in the US. The company says it worked with officials to remove the affected products on its own. The company said they were sorry for “any stress or trouble [customers] may have experienced because of a false positive result.”
The “higher-than-acceptable” fake results, which say someone has the coronavirus when they don’t, have been reported to the FDA at least 35 times. There have been no false negative findings found. A wrong evaluation, on the other hand, could be life-threatening. It is possible to get the wrong or unneeded treatment, like antiviral and antibody therapy, and have to spend more time away from family and friends, which can be very upsetting. The FDA said this could also make people not take steps, like getting a Covid-19 vaccine.
