Ellume first announced a voluntary recall of some of its rapid antigen tests in October due to an increased chance of false positives. More than 2 million tests are now included in the recall, the US Food and Drug Administration said Wednesday.
More than 2 million of Ellume’s at-home COVID-19 tests have been recalled by the company due to “higher-than-acceptable” false positives.
This recall has been identified by the FDA as a Class I recall, “the most serious type of recall,” as “use of these tests may cause serious adverse health consequences or death.” The FDA said false positives could lead to a delayed diagnosis or treatment of the actual cause of a person’s illness; receiving unnecessary Covid-19 treatment which may have side effects; and disregard for precautions against Covid-19, including vaccination.
The FDA says that there have been 35 reports of false positives, and no reported deaths. The reliability of negative test results is not affected, the agency said.
Tests manufactured February 24 to August 11 and distributed April 13 to August 26 are included in the recall.
“The FDA is continuing to work with Ellume to assess the company’s corrective actions, such as additional manufacturing checks and other corrective steps, to address the reason for the manufacturing issue, and to help ensure that it is resolved and will not recur,” the agency said Wednesday.
Ellume is asking that affected products be removed from shelves and not sold; it advises those who have receive a positive result with one of their tests to have a follow up test to confirm their diagnosis.
In February, the Biden administration announced a $231.8 million award for Ellume USA for production of its at-home tests for the US.
But demand for home tests has remained high and supply limited. This fall, the Biden administration announced billions more dollars to help make more tests available.
It’s Prematurity Awareness Month, And Denver Neonatalogist Says Infant Health Care Is Improving
One in 10 babies in the U.S. is born premature. November is Prematurity Awareness Month, a time to help support moms and babies and raise awareness of the prematurity health crisis.
Dr. Anna Zimmerman is a neonatalogist in Denver and says pre-term births happen and they are not the fault of moms. She says the conception in the U.S. is you get pregnant and you are going to have a healthy baby. Most of the time it goes that way for more than 90% of mothers. A pre-term baby is one that is born before 37 weeks. Babies born from 22 weeks up until 26 weeks are considered extremely preterm deliveries.
Preterm birth is a leading cause of infant mortality and the babies who survive can have short and long-term health problems.
Premature babies are cared for in the newborn intensive care unit. They require nursing specialists along with the equipment needed to care for preterm babies.
Some of the babies need help breathing and get that from a ventilator or a breathing tube. The babies also need special eye exams because a baby’s eyes don’t mature until past his or her due date.
Dr. Zimmerman says some babies can spend three to four months in the intensive care, and while it’s really difficult the majority of babies do really well. The outcomes are better today than they were 10, 20 or 30 years ago.