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Date Issued: October 5, 2021
The U.S. Food and Drug Administration (FDA) is alerting test users, caregivers, health care personnel, and the public of the potential for false positive results with certain lots of the Ellume COVID-19 Home Test, due to a recently identified manufacturing issue. For these tests, a “false positive” is a test result that indicates that a person has the virus when they do not actually have it. Negative results do not appear to be affected by the manufacturing issue.
The FDA is working closely with Ellume to assess the company’s additional manufacturing checks and other corrective steps to help ensure that the issue is resolved.
A complete list of affected Ellume COVID-19 Home Tests can be found onEllume’s website.
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https://www.fda.gov/medical-devices/...ring-issue-fda
The U.S. Food and Drug Administration (FDA) is alerting test users, caregivers, health care personnel, and the public of the potential for false positive results with certain lots of the Ellume COVID-19 Home Test, due to a recently identified manufacturing issue. For these tests, a “false positive” is a test result that indicates that a person has the virus when they do not actually have it. Negative results do not appear to be affected by the manufacturing issue.
The FDA is working closely with Ellume to assess the company’s additional manufacturing checks and other corrective steps to help ensure that the issue is resolved.
A complete list of affected Ellume COVID-19 Home Tests can be found onEllume’s website.
...
https://www.fda.gov/medical-devices/...ring-issue-fda