CLASS I ONGOING Device recall · Reported 17 Nov 2021 · FDA Enforcement Report
Covid-19 Home Test recalled by ELLUME
Ellume is recalling Covid-19 Home Test, distributed in Minnesota, New York, Pennsylvania, Rhode Island, Utah, Washington. The recall was initiated on 1 Oct 2021 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0183-2022
- FDA event ID
- 88801
- Recalling firm
- Ellume, East Brisbane, N/A
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 1 Oct 2021
- FDA classified
- 10 Nov 2021
- Reported
- 17 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Test Kits & Diagnostics
Timeline
| 1 Oct 2021 | Recall initiated by company | |
| 10 Nov 2021 | Classified by FDA | +40 days |
| 17 Nov 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Due to a higher rate of false positive test results.
Product as listed by the FDA
Ellume COVID-19 Home Test
Where it was distributed
U.S.: MN, NY, PA, RI, UT, WA. O.U.S.: Not provided
Questions about this recall
Why was it recalled?
Due to a higher rate of false positive test results.
Which lots are affected?
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;
Where was it sold?
U.S.: MN, NY, PA, RI, UT, WA. O.U.S.: Not provided
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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