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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90773

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

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Event summary

Timeline bucket
August 09, 2022
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Jiangsu Well Biotech Co.,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

Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

Z-0001-2023
Recall number
Z-0001-2023
Initiated
August 09, 2022
Classification
Class I
Status
Ongoing
Quantity
620,000 tests

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.

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

Distribution of COVID-19 Ag Rapid Test kits in the U.S. without an Emergency Use Authorization, or a Pre-Market Approval or Clearance.

Code information

Catalog Number: CO-02 UDI-DI Code: No UDI Codes provided Lot Numbers: 202107192, 202108231, 202109231, 202111082, 202110111, 202201102,

Distribution pattern

U.S.: CA (pending firm supplying additional distribution locations/consignee list). O.U.S.: N/A