Z-0183-2022Class I

Ellume COVID-19 Home Test

Name: Z-0183-2022 Ellume COVID-19 Home Test
Creator: Ellume Ltd
Published: 2021-10-01
License: https://open.fda.gov/license/

Ellume Ltd / initiated 2021-10-01 / Open, Classified / root cause: manufacturing process

FDA source

ELLUME LTD began a recall of Ellume COVID-19 Home Test on 2021-10-01. FDA classified it as Class I and gives the reason as "Due to a higher rate of false positive test results". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0183-2022
Classification: Class I
Status: Open, Classified
Initiated: 2021-10-01
Posted: 2021-11-10
Recalling firm: Ellume Ltd
Product: Ellume COVID-19 Home Test
Product code: QKP Coronavirus Antigen Detection Test System.
Reason for recall: Due to a higher rate of false positive test results.
Root cause tag: manufacturing process
FDA 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 [email protected] 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
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0183-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0183-2022	Class I	Ongoing	Voluntary: Firm initiated	2021-11-17	2021-11-10

Product code QKP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)