ELLUME LTD: Medical Device Recall in 2021 - (Recall #: Z-0183-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Ellume COVID-19 Home Test

Product Classification:

Class I

Date Initiated: October 1, 2021

Date Posted: November 17, 2021

Recall Number: Z-0183-2022

Event ID: 88801

Reason for Recall:

Due to a higher rate of false positive test results.

Status: Ongoing

Product Quantity: 427,994 kits

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

Voluntary or Mandated:

Voluntary: Firm initiated