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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 91300

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

Open FDA event record

Event summary

Timeline bucket
December 08, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Detect Headquarters

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

Detect Covid-19 Test Product/Model Number: 21205

Z-0879-2023
Recall number
Z-0879-2023
Initiated
December 08, 2022
Classification
Class II
Status
Ongoing
Recalling firm
Detect Headquarters
Quantity
10142 (US); 960 OUS

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is an increased chance that the tests from affected lots may give false negative results. Health risks resulting from a false negative result include delay or lack of supportive treatment and lack of monitoring of infected individuals and their household or other close contacts for symptoms resulting in increased risk of spread of COVID-19 within the community.

Code information

HY263, HY264, and HB264 Expiration 01JAN2023

Distribution pattern

Domestic distribution nationwide. Foreign distribution to Hong Kong.