FDA-Device2021-04-07Class II
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.
LumiraDx
Hazard
Two lots of test strips failed QC testing using blank buffer due to false positives.
Sold states
US nationwide distribution.
Affected count
2186 devices
Manufactured in
221 Crescent St, Waltham, MA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1312-2021Don't want to check this manually?
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