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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:213949

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

Official recall number

Z-1979-2025

Evidence summary

Product code
QKP
Recall status
Open, Classified
Event initiated
January 24, 2025
Root cause
No Marketing Application
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1979-2025

Field note

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