Z-1979-2025Class II

Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number...

Name: Z-1979-2025 Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number...
Creator: Guangzhou Pluslife Biotech Co., Ltd.
Published: 2025-01-24
License: https://open.fda.gov/license/

Guangzhou Pluslife Biotech Co., Ltd. / initiated 2025-01-24 / Open, Classified

FDA source

Guangzhou Pluslife Biotech Co., Ltd. began a recall of 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... on 2025-01-24. FDA classified it as Class II and gives the reason as "Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA)". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1979-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-01-24
Posted: 2025-06-13
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
Product code: QKP Coronavirus Antigen Detection Test System.
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).
FDA 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 [email protected] Mon-Fri, 9:00 AM to 6:00 PM CST Distributor by Altruan : After-Sales Team [email protected] Mon-Fri, 9:00 AM to 5:00 PM CET
Quantity in commerce: 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.
Product codes and lots: Model/Catalog Number: RM1010202; Lot numbers: All lots of the COVID-19 test kits in the U.S.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1979-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1978-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-25	2025-06-13
Z-1979-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-25	2025-06-13

Product code QKP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)