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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:185885

Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 directly from nasal swab samples collected from individuals suspected of COVID-19 by their healthcare provider within the first twelve days of symptom onset.

Official recall number

Z-1312-2021

Evidence summary

Product code
QKP
Recall status
Terminated
Event initiated
February 03, 2021
Root cause
Process design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1312-2021