LumiraDx Coronavirus Antigen Test Strips Recalled for False Positives
LumiraDx is recalling 2,186 coronavirus antigen test strips because two lots failed quality control testing and produced false positives.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves false positives from quality control failures, which is a significant diagnostic error but does not involve reported injuries or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
LumiraDx is recalling 2,186 units of its Coronavirus antigen detection test system. The affected products are identified by catalog number L001000330001. These tests are intended for the qualitative detection of the nucleocapsid protein antigen to SARS-CoV-2 from nasal swab samples.
The recall was initiated because two lots of test strips failed quality control testing using blank buffer, resulting in false positives. The products were distributed nationwide in the United States.
Consumers who have these specific test strips should stop using them and contact LumiraDx for further instructions.
The recalled product
- 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 twel
- Manufacturer
- LumiraDx
- Category
- Medical Device — Diagnostic Test
- Affected units
- 2,186
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- catalog #: L001000330001
Distribution
Distributed nationwide across the United States.
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