FDA Medical devices recall ·
Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing… recall
- Recall number
- Z-1979-2025
- Date
- (initiated January 24, 2025)
- Company / brand
- Guangzhou Pluslife Biotech Co., Ltd.
Room 402, Guangzhou, N/A, China - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 1850 boxes
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model/Catalog Number: RM1010202; Lot numbers: All lots of the COVID-19 test kits in the U.S.
Distribution
Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Hong Kong, Australia, Singapore, Palestine, Russia, Ecuador, Papua New Guinea, Indonesia, South Africa, Zimbabwe, Brazil, Tunisia, Samoa, Algeria, Romania, Czech Republic, Thailand, South Korea, Malaysia, Fiji, Nepal, Peru, Mexico, Bahamas, Chile, India, Germany, France, Portugal, Vietnam, Spain, Poland, Latin American Region, Italy, Cameroon, Slovakia, Greece, Hungary Bahrain, Estonia, and Ukraine.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1979-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.