Reported Jun 25, 2025 · Ongoing
Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card Model/Catalog Number: RM1010202…
Guangzhou Pluslife Biotech Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Guangzhou Pluslife Biotech Co., Ltd. · Room 402 · Guangzhou, N/A · N/A
Is this the product you have?
- Brand NamePluslife
- SARS-CoV-2 Card Product NameSARS-CoV-2 Nucleic
- Acid Testing Card Model/Catalog NumberRM1010202
- Software VersionN/A
- Product Description1
- Product Overview Product NameSARS-CoV-2
- Nucleic Acid Testing Card Trade NamePluslife SARS-CoV-2 Card 2
- Product compositionThe 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)
- ComponentNO
- Lot codes and dates
- Model/Catalog NumberRM1010202
- Lot numbersAll lots of the COVID-19 test kits in the U.S
- Amount recalled
- 1850 boxes
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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