LumiraDx 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
LumiraDx
Lot Codes / Batch Numbers
catalog #: L001000330001
Products Sold
catalog #: L001000330001
LumiraDx is recalling Coronavirus antigen detection test system - Product Usage: intended for the qualitative detection of due to Two lots of test strips failed QC testing using blank buffer due to false positives.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Two lots of test strips failed QC testing using blank buffer due to false positives.
Recommended Action
Per FDA guidance
On 2/23/2020, LumiraDx issued an Urgent Device Medical Corrective Field Action notice to customers, advising them of a mandatory field corrective action in the form of a software update for the LumiraDx SARS-CoV-2 Antigen (Ag) Test.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026