Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1978-2025 — 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: T

U.S. FDA — Device Enforcement · China · 2025-01-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1978-2025
Date of alert
2025-01-24
Country / jurisdiction
China
Risk level
Class II
Risk type
recall
Brand
Guangzhou Pluslife Biotech Co., Ltd.
Product category
device
Product type
Devices
Reported risk: Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.