RecallWatchMedical Device Safety

Recall database

Coronavirus Antigen Detection Test System. recalls

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 1–2 of 2 recalls

Class IIOngoingZ-1979-2025

Guangzhou Pluslife Biotech Co., Ltd. recalls Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Car…

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

Guangzhou Pluslife Bio…Jun 25, 2025

Class IIOngoingZ-1978-2025

Guangzhou Pluslife Biotech Co., Ltd. recalls Brand Name: MiniDock Product Name: Integrated Nucleic Acid Testing Device Model/Catal…

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

Guangzhou Pluslife Bio…Jun 25, 2025