# FDA recall Z-1978-2025

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

## Product

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

## 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-1978-2025
- **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-1978-2025

## Citation

> AI Analytics. FDA recall Z-1978-2025. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1978-2025. Source: US FDA. Licensed CC0.

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