Pluslife SARS-CoV-2 Card SARS-CoV-2 Nucleic Acid Testing Card recall — FDA Z-1979-2025
Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).
Overview of recall records associated with Guangzhou Pluslife Biotech Co., Ltd., including dates, categories and classifications where available.
Classification mix: Class II: 2.
Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).
Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).
This page summarizes recall records in which the official source identifies Guangzhou Pluslife Biotech Co., Ltd. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.