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LumiraDx recalls Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of the nucleocapsid pr
Recalled April 7, 2021 · FDA recall Z-1312-2021 · LumiraDx
Hazard
Two lots of test strips failed QC testing using blank buffer due to false positives. · FDA Class II
Units
2186 devices
Sold at
US nationwide distribution.
Description
Two lots of test strips failed QC testing using blank buffer due to false positives.
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.
Manufacturer(s)
LumiraDx
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →