Australian medical tech maker Alum said it had recalled nearly 200,000 at-home COVID-19 tests in the United States over the growing possibility of false positives.
Last year Elume’s rapid at-home coronavirus test became the first in the US to receive emergency use authorization.
The US Food and Drug Administration on Tuesday issued an alert on “the potential for false positive results with certain quantities of alum COVID-19 home test due to a recently identified manufacturing issue.”
“The negative results are not affected by the manufacturing issue,” the statement said.
“The FDA is working closely with Alum to assess the company’s additional manufacturing investigations and other corrective steps to ensure that the issue is resolved.”
A spokesman for Alum told AFP on Wednesday that of the 3.5 million tests sent to the United States, 195,000 were affected.
These also included tests provided to the Defense Department for distribution to community health programs.
In a statement on October 1, the company said the voluntary recall was ordered after false positive results were found in certain product batches at higher-than-expected rates.
Founder Sean Parsons said, “I offer my sincere apologies and apologies to the entire company—I apologize for the stress or hardships people have experienced because of a false positive result.”
The firm said it had identified the cause of the problem and implemented additional controls, and resumed distributing the test to US retailers.
“We have and will continue to work diligently to ensure test accuracy in all cases,” Parsons said.
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