Guangzhou Pluslife Biotech Co., Ltd.: 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

Recall number

Z-1979-2025

Recalling firm

Guangzhou Pluslife Biotech Co., Ltd.

Product

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

Status

Open, Classified

Initiated

2025-01-24

Posted

2025-06-13

Terminated

not on file

Reason

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

Root cause

No Marketing Application

Action

On January 24, 2025, FORMAL NOTICE REGARDING DISTRIBUTION RESTRICTIONS IN THE U.S. MARKET letters were emailed to distributors. This communication serves to formally notify you that, effective immediately, all authorized distributors of Guangzhou Pluslife Biotech Co., Ltd. are strictly prohibited from marketing, selling, or distributing any Pluslife products to the United States market. In May 2025 an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letters dated May 30, 2025, were sent to the distributor to be sent to consignees. Actions to be taken by the Customer/User: Consumers who still have unused tests manufactured by Pluslife should stop using the device immediately and discard any remaining stock in the trash. - Notice to Distributor: Immediately cease U.S. sales of unauthorized Pluslife devices Issue recall notices to all affected customers in the U.S cooperate fully with the FDA and Pluslife to complete the recall - Company official statement Statement on Prohibition of Unauthorized Sales to the U.S. Market (Published on the Pluslife official website). - Signing the distribution agreement: Prohibiting distributors from selling the unapproved Pluslife products by the FDA in U.S. For assistance, contact: Manufacturer by Pluslife: Marketing Team recall@pluslife.com Mon-Fri, 9:00 AM to 6:00 PM CST Distributor by Altruan : After-Sales Team pluslife@altruan.com Mon-Fri, 9:00 AM to 5:00 PM CET

Quantity

1850 boxes

Distribution

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.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

QKP

Firm FEI

3037392657

Firm city

Guangzhou

Firm state

not on file

Firm country

China

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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