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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89995

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 09, 2022
Product types
Device
Classifications
Class I
Statuses
Ongoing
Recalling firm wording
Woodside Acquisitions 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

2 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 2

Oral Rapid SARS-CoV-2 Antigen Rapid Test Kit; COVID 19 Test

Z-1044-2022
Recall number
Z-1044-2022
Initiated
April 09, 2022
Classification
Class I
Status
Ongoing
Quantity
34,240 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.

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

Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.

Code information

All lots

Distribution pattern

US distributions to states of: AL and GA.

device · product 2 of 2

Joysbio SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold); COVID 19 Test

Z-1045-2022
Recall number
Z-1045-2022
Initiated
April 09, 2022
Classification
Class I
Status
Ongoing
Quantity
17,000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.

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

Firm distributed tests which have not been cleared or authorized for marketing or distribution in the United States.

Code information

All lots

Distribution pattern

US distributions to states of: AL and GA.