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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96896

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

Open FDA event record

Event summary

Timeline bucket
January 24, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Guangzhou Pluslife 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

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

Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catalog Number: PM001 Software Version: N/A Product Description: 1. Product Overview 1.1 Product Name: Integrated Nucleic Acid Testing Device Brand Name: MiniDock 1.2 Model: PM001 2.Product composition: This device consists of the main unit, power cord, data cable, power adapter, chip bracket, and instruction manual packaging. Component: No

Z-1978-2025
Recall number
Z-1978-2025
Initiated
January 24, 2025
Classification
Class II
Status
Ongoing
Quantity
541 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).

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

Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).

Code information

Model/Catalog Number: PM001; Lot numbers: All of the Devices in the U.S.

Distribution pattern

Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Hong Kong, Australia, Singapore, Palestine, Russia, Ecuador, Papua New Guinea, Indonesia, South Africa, Zimbabwe, Brazil, Tunisia, Samoa, Algeria, Romania, Czech Republic, Thailand, South Korea, Malaysia, Fiji, Nepal, Peru, Mexico, Bahamas, Chile, India, Germany, France, Portugal, Vietnam, Spain, Poland, Latin American Region, Italy, Cameroon, Slovakia, Greece, Hungary Bahrain, Estonia, and Ukraine.

device · product 2 of 2

Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software Version: N/A Product Description: 1. Product Overview Product Name: SARS-CoV-2 Nucleic Acid Testing Card Trade Name: Pluslife SARS-CoV-2 Card 2.Product composition:The kits consists of SARS-CoV-2 Reaction Card (10 pcs), Nucleic Acid ReleasingAgent 01 (10 pcs), Disposable SamplingSwab (10 pcs), and Waste Bag (10 pcs). Component: NO

Z-1979-2025
Recall number
Z-1979-2025
Initiated
January 24, 2025
Classification
Class II
Status
Ongoing
Quantity
1850 boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).

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

Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).

Code information

Model/Catalog Number: RM1010202; Lot numbers: All lots of the COVID-19 test kits in the U.S.

Distribution pattern

Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Hong Kong, Australia, Singapore, Palestine, Russia, Ecuador, Papua New Guinea, Indonesia, South Africa, Zimbabwe, Brazil, Tunisia, Samoa, Algeria, Romania, Czech Republic, Thailand, South Korea, Malaysia, Fiji, Nepal, Peru, Mexico, Bahamas, Chile, India, Germany, France, Portugal, Vietnam, Spain, Poland, Latin American Region, Italy, Cameroon, Slovakia, Greece, Hungary Bahrain, Estonia, and Ukraine.