Guangzhou Pluslife Biotech Co., Ltd. 2025-06-25 Health serious FDA
Health · FDA · Recall #FDA-Z-1979-2025
Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card … Recall
Issued June 25, 2025 · Guangzhou Pluslife Biotech Co., Ltd.
In June 2025, Guangzhou Pluslife Biotech Co., Ltd. recalled the Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card …, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).
What you should do
- 1 Stop using Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic Acid Testing Card … right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Guangzhou Pluslife Biotech Co., Ltd. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Guangzhou Pluslife Biotech Co., Ltd.
- Category
- Health
- Recall date
- June 25, 2025
- Units affected
- Not reported
- Sold at
- Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: Hong Kong, Australia, Singapore, Palestine, Russia, Ecuador, Papu
- Recall number
- FDA-Z-1979-2025
- Made in
- China
- Issuing agency
- FDA
In context
- Guangzhou Pluslife Biotech Co., Ltd. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.