ELLUME LTD: Ellume COVID-19 Home Test

Recall number

Z-0183-2022

Recalling firm

ELLUME LTD

Product

Ellume COVID-19 Home Test

Status

Open, Classified

Initiated

2021-10-01

Posted

not on file

Terminated

not on file

Reason

Due to a higher rate of false positive test results.

Root 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

427,994 kits

Distribution

U.S.: MN, NY, PA, RI, UT, WA. O.U.S.: Not provided

Lot, serial or model codes

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;

510(k) numbers

not on file

PMA numbers

not on file

Product code

QKP

Firm FEI

3014862188

Firm city

Brisbane

Firm state

East

Firm country

Australia

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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