Brand Name: Pluslife SARS-CoV-2 Card Product Name: SARS-CoV-2 Nucleic… — Class II medical device recall Z-1979-2025
Ongoing recall by Guangzhou Pluslife Biotech Co., Ltd., reported 2025-06-25, distributed nationwide. Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g.,
| Recall number | Z-1979-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Guangzhou Pluslife Biotech Co., Ltd., Guangzhou, N/A, China |
| Recall initiated | 2025-01-24 |
| Classified | 2025-06-13 |
| Reported by FDA | 2025-06-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BH, BR, BS, CL, CZ, DE, DZ, EC, EE, ES, FR, GR, HK, HU, ID, IN, IT, KR, MX, MY, NP, PE, PL, PT, RO, RU, SG, SK, TH, TN, UA, VN, ZA |
| Quantity | 1,850 boxes |
| Lot numbers | COVID-19 |
| Model numbers | RM1010202 |
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.Product composition:The 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). Component: NO
Reason for recall
Devices were distributed in the U.S. market without obtaining the required FDA premarket authorization (e.g., 510(k) clearance or PMA).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1979-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.