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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89755

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

Open FDA event record

Event summary

Timeline bucket
January 09, 2022
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Acon Biotech (Hangzhou) 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

Flowflex SARS-CoV-2 Antigen Rapid Test (Self-Testing), CE marked

Z-0945-2022
Recall number
Z-0945-2022
Initiated
January 09, 2022
Classification
Class II
Status
Ongoing
Quantity
303,760

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test kits are being recalled from the U.S. market because use may lead to inaccurate test results, including false negative or false positive test results.

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

Non-EUA authorized, CE marked, SARS-CoV-2 antigen rapid test kits are being recalled from the U.S. market because use may lead to inaccurate test results, including false negative or false positive test results.

Code information

Lots: COV1080201, COV1105014

Distribution pattern

US: MD, PA International Distribution to countries of: Hungary and China.