Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88801

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 01, 2021
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
ELLUME LTD

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Ellume COVID-19 Home Test

Z-0183-2022
Recall number
Z-0183-2022
Initiated
October 01, 2021
Classification
Class I
Status
Ongoing
Recalling firm
ELLUME LTD
Quantity
427,994 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to a higher rate of false positive test results.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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