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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89485

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

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Event summary

Timeline bucket
January 27, 2022
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
E25Bio, Inc.

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

E25Bio COVID-19 Direct Antigen Rapid Test ; E25Bio COVID-19 DART Kit

Z-0564-2022
Recall number
Z-0564-2022
Initiated
January 27, 2022
Classification
Class I
Status
Terminated
Recalling firm
E25Bio, Inc.
Quantity
73,300 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was distributed without sufficient directions or controls in place.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

No Marketing Application

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Test is not authorized, cleared, or approved by FDA for clinical diagnostic or screening purposes. It was distributed without sufficient directions or controls in place.

Code information

Lot numbers are unavailable. The following Purchase Orders and Dates are affected: Purchase Order/Invoice Number Date 1006 10/13/2020 1007 11/13/2020 1008 11/25/2020 1009 12/18/2020 1010 01/07/2021 1011 01/07/2021 1012 01/07/2021 1011 01/07/2021 1015 1/29/2021 1016 02/03/2021 1019 2/26/2021 1017 2/23/2021 1021 3/05/2021 1023 3/19/2021 1027 04/05/2021 1039 11/03/2021 1040 11/03/2021 1028 4/16/2021 1029 5/10/2021 1032 09/03/2021 1073 11/27/2020

Distribution pattern

US Nationwide distribution in the states of MA, FL, and HI.