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Recall Observatory FDA recall evidence

Device product

Ellume COVID-19 Home Test

Z-0183-2022

October 01, 2021

Class I

Product summary

Firm
ELLUME LTD
Event
Event 88801
Status
Ongoing
Classification
Class I
Quantity
427,994 kits
Official record key
device-enforcement:Z-0183-2022

Official wording

Reason: Due to a higher rate of false positive test results.

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;

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to a higher rate of false positive test results.