COVID-19 Home Test by Ellume: Class I Recall - Due to Potential False Positive SARS-CoV-2 Test Results

Washington State Department of Health sent this bulletin at 11/18/2021 08:12 AM PST

FDA MedWatch - COVID-19 Home Test by Ellume:

U.S. Food and Drug Administration sent this bulletin at 11/17/2021 12:15 PM EST

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: COVID-19 Home Test by Ellume: Class I Recall - Due to Potential False Positive SARS-CoV-2 Test Results

AUDIENCE: Patient, Health Professional, Risk Manager, Pharmacy

ISSUE: Ellume is recalling certain lots of the COVID-19 Home Test because they have higher-than-acceptable false positive test results for SARS-CoV-2. The reliability of negative test results is not affected.

The recall described in this notice is for the same issue that was announced in Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue FDA Safety Communication on October 5, 2021.

There have been 35 reports of false positive results sent to the FDA and no deaths reported.

For more information about this recall/alert, click on the red button "Read Recall" below.

BACKGROUND: The Ellume COVID-19 Home Test is an antigen test that detects proteins from the SARS-CoV-2 virus from a nasal sample in people two years of age or older.

RECOMMENDATIONS: On October 1, 2021, Ellume sent all impacted customers an “Urgent: Medical Device Recall” letter requesting they:

Remove affected products from shelves and stop sales.
Quarantine the affected products immediately.
Contact their Ellume sales representatives for more instructions on disposal.
Complete and send the acknowledgement form that was included with the recall letter to productsafety@ellume.com.
Share the recall letter with any accounts or additional locations, if the affected products have been further distributed.
Immediately notify Ellume of any accounts or additional locations that may have received the affected products.

Ellume is advising test users and caregivers to:

Check if their product is from an affected lot. If their product is affected, read recall for more instructions.
Contact their health care provider, urgent care facility, or other COVID-19 testing site and request a COVID-19 molecular diagnostic test to confirm the positive test result if they used a test from one of the affected lots in the last two weeks and have not already had a follow-up molecular diagnostic test to confirm the positive test result.

The FDA issued Potential for False Positive Results with Certain Lots of Ellume COVID-19 Home Tests Due to a Manufacturing Issue FDA Safety Communication on October 5, 2021 recommending that test users and caregivers:

Contact your health care provider, urgent care facility, or other COVID-19 testing site if:
- You received a positive test result using one of the affected lots of the Ellume COVID-19 Home Test more than two weeks ago, and
- You did not receive a positive result from a different COVID-19 test at the time of the original Ellume positive test result. A health care provider can help you decide what next steps you should take. You should not assume that you had COVID-19 or have immunity to COVID-19. You should continue to take recommended precautions, including vaccination, to avoid COVID-19 infection, following the Centers for Disease Control and Prevention’s guidelines.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.