Ellume expands recall of rapid at-home COVID-19 tests
Ellume has expanded its recall of rapid at-home COVID-19 antigen tests to about 2 million tests, the Food and Drug Administration said in an this week. Ellume last month recalled certain lots of its COVID-19 Home Test due to an increased chance of false-positive results. FDA has classified the recall as a Class I recall, the most serious type.
鈥淭he FDA is continuing to work with Ellume to assess the company鈥檚 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,鈥 the agency said.
Related News Articles
Headline
The White House Feb. 1 announced it placed tariffs on imported goods from Canada, Mexico and China. The tariffs for Mexico and Canada have since been delayed鈥
Headline
CDC recommends two doses of COVID-19 vaccine for older individuals, lowers pneumococcal vaccine age聽
The Centers for Disease Control and Prevention last week endorsed a recommendation for people aged 65 and older and for immunocompromised individuals to鈥
Headline
The Centers for Medicare & Medicaid Services Oct. 22 released final guidance detailing reporting requirements for the hospital respiratory data condition鈥
Headline
The Food and Drug Administration Aug. 22 granted emergency use authorization for two new combined COVID-19 and influenza tests. The Nano-Check Influenza-COVID-鈥
Headline
The Centers for Disease Control and Prevention's COVID-19 data tracker shows an 18.1% test positivity rate for the week ending Aug. 10, the highest it has been鈥
Headline
The Centers for Disease Control and Prevention Aug. 13 issued an advisory alerting of an uptick of cases of parvovirus B19 across the U.S. Parvovirus B19 is a鈥