Class 1 Device Recall Ellume COVID19 Home Test

• Date Initiated by Firm: October 01, 2021
• Create Date: November 10, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0183-2022
• Recall Event ID: 88801
• Product Classification: Coronavirus antigen detection test system. - Product Code QKP
• Product: Ellume COVID-19 Home Test
• Code Information: Catalogue number I-SRS-C-01 Master Lot Numbers: 21047-4; 21047-5; 21089-1; 21117-1; PF06Z-H; 21099-1; 21124-1; 21125-1; PF03X-H; PF057-H; PF05W-H; PF069-H; PF06E-H; PF06N-H; PF06Z-H; PG080-H; PG08H-H; PH08X-H
• Recalling Firm/ Manufacturer: ELLUME LTD; 57 Didsbury St; East Brisbane Australia
• Manufacturer Reason for Recall: Due to a higher rate of false positive test results.
• FDA Determined Cause: Process control
• Action: On 10/01/2021, the Recalling Firm communicated an "URGENT: MEDICAL DEVICE RECALL" Notification letter via email to its: -Distributors/retailer -Customers/users that include customers that have used the products within 2 weeks and beyond 2 weeks. The communications informed customer that the Recalling Firm has received a number of complaints stating false positive test results for it COVID-19 Home Test kits. If consumers have used an affected product before 09/17/2021 and tested positive are advised that their test results could have been incorrect. For Distributor and Retailers, they are instructed to: 1. Remove affected products from their shelves and cease sales and distibution. 2. Quarantine the affected products immediately 3. Contact the Recalling Firm's sales representatives for further instructions on the disposal of affected product. 4.Complete and return the attached Acknowledgement Form acknowledging their receipt of the Recall Notification and confirming that they have returned or destroyed the affected product. Return Acknowledgement Form to the Recalling Firm at productsafety@ellume.com 5. If the affected products have been further distributed, notify any accounts or additional locations and share the Recall Notification with them 6. Immediately notify the Recalling Firm of any accounts or additional locations that may have received the affected product. For Consumers that have used the affected products: Users that have used the affected products within the last two weeks are being informed and instructed to: 1. If they have received a positive test result, this result may be incorrect and they should contact a healthcare professional immediately and notify them of this recall and ask to obtain a confirmatory test (i.e., molecular or RT-PCR). 2. If they have already had a confirmatory test that confirms they DO have COVID-19, disregard this letter and follow their healthcare professional's advice and CDC guidance on self-isolation,
• Quantity in Commerce: 427,994 kits
• Distribution: U.S.: MN, NY, PA, RI, UT, WA. O.U.S.: Not provided
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.