medical Class II Updated 2021-04-07

LumiraDx recalls Coronavirus antigen detection test system - Product Usage: i

Recalled Product

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.


Hazard / Issue

Two lots of test strips failed QC testing using blank buffer due to false positives.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: catalog #: L001000330001
View official government recall

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