Pluslife SARS-CoV-2 Card Test Kits Recalled for Lack of FDA Authorization
Pluslife SARS-CoV-2 Card nucleic acid testing kits were distributed in the U.S. without required FDA premarket authorization. The FDA is recalling approximately 1,850 boxes distributed nationwide and internationally.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall for a device distributed without premarket authorization. No reported illnesses, injuries, or adverse events are stated in the source. The hazard is regulatory non-compliance rather than an inherent product defect or contamination, making this a precautionary recall.
Plain-English summary
The FDA is recalling the Pluslife SARS-CoV-2 Card (model RM1010202), a nucleic acid testing card manufactured by Guangzhou Pluslife Biotech Co., Ltd. The product was distributed in the U.S. market without obtaining required FDA premarket authorization, such as 510(k) clearance or a PMA (Premarket Approval).
Approximately 1,850 boxes of the product have been distributed. The kits were supplied nationwide in the U.S. and internationally to multiple countries including Hong Kong, Australia, Singapore, Russia, South Africa, Brazil, Mexico, India, Germany, France, Spain, Poland, Italy, and others.
Consumers and healthcare providers in possession of this product should discontinue use and contact the manufacturer or seek guidance from their local health authority regarding proper handling and disposal.
The recalled product
- 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
- Manufacturer
- Guangzhou Pluslife Biotech Co., Ltd.
- Hazard
- unauthorized-distribution
- missing-fda-authorization
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Model/Catalog Number: RM1010202
- Lot numbers: All lots of the COVID-19 test kits in the U.S.
Distribution
Distributed nationwide across the United States.
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