# FDA recall Z-1979-2025

> **Guangzhou Pluslife Biotech Co., Ltd.** · Class II · device recall initiated 2025-01-24.

## 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

## 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).

## 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.

## Key facts

- **Recall number:** Z-1979-2025
- **Recalling firm:** Guangzhou Pluslife Biotech Co., Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-01-24
- **Report date:** 2025-06-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Guangzhou, N/A, China

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1979-2025

## Citation

> AI Analytics. FDA recall Z-1979-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1979-2025. Source: US FDA. Licensed CC0.

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