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FDAJanuary 24, 2025device

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 co...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).

What to do

FDA enforcement status: Ongoing

Brands named

guangzhou pluslife biotechguangzhouguangzhou pluslife

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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