Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing… — Class II medical device recall Z-1978-2025
Ongoing recall by Guangzhou Pluslife Biotech Co., Ltd., reported 2025-06-25, distributed nationwide. Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g.,
| Recall number | Z-1978-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Guangzhou Pluslife Biotech Co., Ltd., Guangzhou, N/A, China |
| Recall initiated | 2025-01-24 |
| Classified | 2025-06-13 |
| Reported by FDA | 2025-06-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BH, BR, BS, CL, CZ, DE, DZ, EC, EE, ES, FR, GR, HK, HU, ID, IN, IT, KR, MX, MY, NP, PE, PL, PT, RO, RU, SG, SK, TH, TN, UA, VN, ZA |
| Quantity | 541 units |
| Model numbers | 2.PRODUCT, PM001 |
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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1978-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.