Pluslife SARS-CoV-2 Nucleic Acid Testing Cards (model RM1010202) were distributed without FDA premarket authorization. Consumers should check if they have these kits and contact the manufacturer for details.
Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).
Pluslife SARS-CoV-2 Nucleic Acid Testing Cards (model RM1010202) were recalled because they were sold in the U.S. without proper FDA approval. This means the products may not be safe or effective for use.
The products were distributed without the required FDA premarket authorization, meaning they may not meet safety and effectiveness standards. This could lead to inaccurate test results or other health risks if used improperly.
Anyone who purchased the Pluslife SARS-CoV-2 Nucleic Acid Testing Cards (model RM1010202) in the U.S. is affected. People using these kits for COVID-19 testing are most at risk due to potential lack of regulatory approval.
Check for the model number RM1010202 on the Pluslife SARS-CoV-2 Nucleic Acid Testing Cards. All lots of these kits sold in the U.S. are affected.
Look for the model number RM1010202 on the Pluslife SARS-CoV-2 Nucleic Acid Testing Cards.
The products were distributed in the U.S. without the required FDA premarket authorization, which means they may not be safe or effective.
The recall record does not specify a stop-use instruction, so you should check the product details and contact the manufacturer for further guidance.
Check for the model number RM1010202 on the Pluslife SARS-CoV-2 Nucleic Acid Testing Cards. All lots sold in the U.S. are affected.
We’ve drafted a message you can send Pluslife to request your refund or repair — edit it as you like.
Subject: Recall Z-1979-2025 — Pluslife Pluslife Hello, I own a Pluslife that is covered by recall Z-1979-2025 from Pluslife. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
