Ellume COVID-19 Home Test Voluntary Recall. Click here.

Voluntary Recall Frequently Asked Questions

Voluntary Recall Frequently Asked Questions

1. I just heard about the recall. How can I find out if my test has been affected and if I am eligible for a replacement test?

  • Access our recall web form to check whether your test has been affected and to request a replacement test.

2. Where can I find a list of affected tests?

  • The easiest way is to find out if your test has been affected is to use the recall web form.
  • You can also find a list of affected LOTs here.

3. I have already performed a test. Where do I find my analyzer ID?

If you have already used a test, your analyzer ID can be found by

  • Checking within the app by tapping Menu – Test Results.
  • Checking your result email.

4. I previously performed a test and received a negative result. Am I affected by the recall?

  • No, the reliability of negative results is unaffected by this issue and are not included within this recall

5. I tried to perform a test. Why is the app blocking me and showing a recall notice?

  • We have implemented a notice within the app for all affected tests to avoid the risk of consumers receiving potentially false positive results.
  • Access our recall web form to check whether your test has been affected and for additional information.

6. My test is not part of the recall and I have a concern with my result. What should I do?

  • For all inquiries not related to the recall, please submit a customer support ticket here

7. I have an unused test from an affected LOT, can I still use it?

  • No, tests from affected LOTs cannot be used.
  • Customers who attempt to use affected tests will be notified within the app that the test has been recalled.
  • Access our recall web form to confirm if your test has been affected and to request a replacement.

8. I have an unused test which has been affected by the recall. Why am I required to complete the steps to retrieve the analyzer ID?

  • Ellume requires the analyzer ID (unique code) of unused tests to allow us to comprehensively evaluate the effectiveness of our recall and stock retrieval activities.
  • This data is required for our reporting to the FDA.
  • Access our recall web form to check whether your test has been affected and for additional information.

9. I have bought multiple tests which have not been used yet and are from an affected LOT. What should I do?

  • If you have multiple unused tests from an affected LOT, please call Customer Support on 1-888-807-1501 Monday – Friday, 9.00am to 5.00pm ET.