MedWatch — COVID-19 Home Test by Ellume: Class I Recall Due to Potential False Positive Results (11/10/2021)

Summary

FDA MedWatch bulletin sent 11/10/2021 04:35 PM EST about a Class I recall of the COVID-19 Home Test by Ellume due to potential false positive SARS-CoV-2 test results. It says Ellume has identified additional affected lots since the FDA's last update on October 5, 2021, and the total of affected tests is now around 2 million. It says the FDA classified the recall as a Class I recall, the most serious type of recall, and is continuing to work with Ellume to assess the company's corrective actions, such as additional manufacturing checks. It says the FDA will keep the public informed if significant new information becomes available.

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Full text

FDA MedWatch - COVID-19 Home Test by Ellume:

U.S. Food and Drug Administration sent this bulletin at 11/10/2021 04:35 PM EST

If your email program has trouble displaying this email, view as a webpage . MedWatch - The FDA Safety Information and Adverse Event Reporting Program COVID-19 Home Test by Ellume: Class I Recall - Due to Potential False Positive SARS-CoV-2 Test Results Ellume is recalling their COVID-19 Home Test because they have the potential to give false positive SARS-CoV-2 test results. For these tests, a false positive test result shows that a person has the virus when they do not have it. The recall described in this notice is for the same issue that was previously announced in the October 5, 2021, FDA Safety Communication: Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue. Today's FDA's Actions include: The FDA has classified the recall of the Ellume COVID-19 Home Test as a Class I recall, the most serious type of recall. Ellume has identified additional affected lots since our last update on October 5, 2021, and the total of affected tests is now around 2 million. 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 FDA will keep the public informed if significant new information becomes available. Questions? Customers with questions about this recall should call Ellume at 1-888-807-1501 or email productsupport@ellume.com . Read Recall | If your email program has trouble displaying this email, view as a webpage . MedWatch - The FDA Safety Information and Adverse Event Reporting Program COVID-19 Home Test by Ellume: Class I Recall - Due to Potential False Positive SARS-CoV-2 Test Results Ellume is recalling their COVID-19 Home Test because they have the potential to give false positive SARS-CoV-2 test results. For these tests, a false positive test result shows that a person has the virus when they do not have it. The recall described in this notice is for the same issue that was previously announced in the October 5, 2021, FDA Safety Communication: Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue. Today's FDA's Actions include: The FDA has classified the recall of the Ellume COVID-19 Home Test as a Class I recall, the most serious type of recall. Ellume has identified additional affected lots since our last update on October 5, 2021, and the total of affected tests is now around 2 million. 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 FDA will keep the public informed if significant new information becomes available. Questions? Customers with questions about this recall should call Ellume at 1-888-807-1501 or email productsupport@ellume.com . Read Recall | If your email program has trouble displaying this email, view as a webpage . | If your email program has trouble displaying this email, view as a webpage . | MedWatch - The FDA Safety Information and Adverse Event Reporting Program COVID-19 Home Test by Ellume: Class I Recall - Due to Potential False Positive SARS-CoV-2 Test Results Ellume is recalling their COVID-19 Home Test because they have the potential to give false positive SARS-CoV-2 test results. For these tests, a false positive test result shows that a person has the virus when they do not have it. The recall described in this notice is for the same issue that was previously announced in the October 5, 2021, FDA Safety Communication: Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue. Today's FDA's Actions include: The FDA has classified the recall of the Ellume COVID-19 Home Test as a Class I recall, the most serious type of recall. Ellume has identified additional affected lots since our last update on October 5, 2021, and the total of affected tests is now around 2 million. 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 FDA will keep the public informed if significant new information becomes available. Questions? Customers with questions about this recall should call Ellume at 1-888-807-1501 or email productsupport@ellume.com . Read Recall | MedWatch - The FDA Safety Information and Adverse Event Reporting Program COVID-19 Home Test by Ellume: Class I Recall - Due to Potential False Positive SARS-CoV-2 Test Results Ellume is recalling their COVID-19 Home Test because they have the potential to give false positive SARS-CoV-2 test results. For these tests, a false positive test result shows that a person has the virus when they do not have it. The recall described in this notice is for the same issue that was previously announced in the October 5, 2021, FDA Safety Communication: Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue. Today's FDA's Actions include: The FDA has classified the recall of the Ellume COVID-19 Home Test as a Class I recall, the most serious type of recall. Ellume has identified additional affected lots since our last update on October 5, 2021, and the total of affected tests is now around 2 million. 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 FDA will keep the public informed if significant new information becomes available. Questions? Customers with questions about this recall should call Ellume at 1-888-807-1501 or email productsupport@ellume.com . Read Recall | Read Recall | Read Recall

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