Recall Z-1979-2025— Guangzhou Pluslife Biotech Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by Guangzhou Pluslife Biotech Co., Ltd., initiated 2025-01-24. FDA's recall record names no specific 510(k) clearance for this event. Product: Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software Version: N/A Product Description: 1. Product Overview Product Name: SARS-CoV-2 Nucleic Acid Testing Card Trade Name: Pluslife SARS-CoV-2 Card 2.Product composition:The kits consists of SARS-CoV-2 Reaction Card (10 pcs), Nucleic Acid ReleasingAgent 01 (10 pcs), Disposable SamplingSwab (10 pcs), and Waste Bag (10 pcs). Component: NO. Reason: Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA)..
- Recalling firm
- Guangzhou Pluslife Biotech Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-24
- Firm location
- Guangzhou, N/A, China
Product description
Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202 Software Version: N/A Product Description: 1. Product Overview Product Name: SARS-CoV-2 Nucleic Acid Testing Card Trade Name: Pluslife SARS-CoV-2 Card 2.Product composition:The kits consists of SARS-CoV-2 Reaction Card (10 pcs), Nucleic Acid ReleasingAgent 01 (10 pcs), Disposable SamplingSwab (10 pcs), and Waste Bag (10 pcs). 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).
Data sourced from openFDA. This site is unofficial and independent of the FDA.