FDA Issues Class I Recall For Over 2 Million COVID-19 Home Test Kits

By Bill Galluccio

November 11, 2021

Cropped shot of young Asian woman consulting to her family doctor online in a virtual appointment, holding a medical test tube, conducting Covid-19 diagnostic test at home
Photo: Getty Images

The Food and Drug Administration announced it has issued a Class I recall for COVID-19 home test kits made by Ellume because of a high rate of false positives. The Class I recall, which is the most serious type of recall, affects over two million rapid antigen tests. The FDA warned that "use of these tests may cause serious adverse health consequences or death."

The FDA explained that a false positive could result in a "delayed diagnosis or treatment for the actual cause of the person's illness" or cause people to miss school and work. It could also cause people who do not have the disease to undergo unnecessary treatment, which could result in side effects.

The recalled tests were manufactured from February 24 to August 11 and distributed from April 13 to August 26. Ellume has pulled the tests from stores and is advising anybody who received a positive result to get rested for COVID-19. In addition, the company said it has pushed out a software update preventing anybody from using a recalled test kit to get results.

"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 in a statement.

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