Company Announcement

Ellume issues voluntary recall of specific lots of Ellume COVID-19 Home Tests

Frederick, Maryland and Brisbane, Australia October 1, 2021
Updated October 11, 2021.

Digital diagnostics company Ellume today announced it is voluntarily recalling specific lots of the Ellume COVID-19 Home Test, the company’s rapid, at-home COVID-19 antigen test, which has been granted Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA).

There is an increased chance that tests from the affected lot numbers may give a false positive result. The voluntary recall is being taken after specific product lots reported false-positive test result rates higher than was observed in clinical testing. Ellume has investigated the issue, identified the root cause, implemented additional controls and we are continuing to work on resolving the issue that led to this recall. Distribution of Ellume COVID-19 Home Tests to retail and distribution partners has recommenced.

Recall Scope

Ellume is notifying consumers, retailers and distributors affected by the recall. Consumers can find instructions for the replacement of the impacted Ellume COVID-19 Home Tests (see list of affected lot numbers below) at www.ellumecovidtest.com/return.

The affected Ellume COVID-19 Home Tests were distributed to retailers and distributors from April-2021 through August-2021.

Action Required

Ellume is removing the affected product from store shelves. Distributors and retailers with an existing inventory of the lots being recalled should stop use and distribution and quarantine the product immediately. Distributors and retailers who have further distributed the recalled product should notify any accounts or additional locations that may have received the recalled product from them. Distributors and retailers will be contacted by Ellume with specific instructions regarding disposal or return of product. For retailer/distributor instructions or assistance, please contact your Ellume representative.

Actions to be taken by the Consumer

Ellume is advising consumers to visit www.ellumecovidtest.com/return to check whether their product is part of the affected lots and if affected, to receive further instructions.

Consumers who attempt to use affected tests will be notified in the Ellume COVID-19 Home Test app that the test has been recalled and disabled. Consumers will be directed to www.ellumecovidtest.com/return to request a product replacement.

Ellume will directly notify via email consumers who have used an affected product and tested positive in the last 14 days. Consumers who have not already had a confirmatory test should immediately obtain one. Prior to a confirmatory test, consumers should assume they have COVID-19 and should self-isolate and take all necessary precautions

Ellume will also directly notify consumers who used an affected product before 09/27/2021 and tested positive. Consumers who did not obtain a confirmatory test at the time of the Ellume positive test result are advised that their test result could have been incorrect, and they may not have had COVID-19. These consumers should not assume they are immune to COVID-19 and should take precautions to avoid COVID-19 infection including vaccination as per CDC guidelines.

Consumers can contact the Ellume Product Support Team at 1-888-807-1501 (9 a.m. to 5 p.m. ET, Monday through Friday) to arrange a replacement.

If consumers have questions unrelated to this recall, to report an adverse event or product complaint, contact the Ellume Customer Support Team at 1-888-885-6121 (9 a.m. to 9 p.m. ET, Monday through Friday, 10 a.m. to 6 p.m. ET, Weekends).

FDA MedWatch Reporting

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Ellume is voluntarily conducting this recall with the knowledge of the U.S. Food and Drug Administration.

ENDS

About Ellume

Ellume is at the forefront of accurate, rapid and accessible testing that is integral to today’s COVID-19 response and will help ensure the world is prepared for the next infectious disease pandemic. Ellume is a digital diagnostics company that develops, manufactures, and commercializes high-performance, connected products for healthcare professionals and consumers. Ellume’s key focus is on the detection of common infectious diseases which affect the global population across all diagnostic settings; at-home, point-of-care and in-laboratory. Ellume’s suite of products differ from conventional diagnostics through performance, digital connectivity, actionability and simplicity. Its novel detection technology is powered by unique quantum dot nanoparticles and integrates optics, electronics, biologics and software into an intuitive and high-performance digital platform. Ellume has a global public health partnership with QIAGEN for latent TB, and a range of professional products under its ellume·lab brand. Ellume is committed to developing high-quality digital diagnostics that the world can rely on in a health crisis.

Further information can be found at ellumehealth.com.

The Ellume COVID-19 Home Test has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for non-prescription home use. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.