LumiraDx SARS-CoV-2 Antibody Test Strip Modified Outside Approved Scope
LumiraDx recalled SARS-CoV-2 Antibody Test Strips after discovering modifications were made outside the FDA-approved Emergency Use Authorization scope. The recall affects 635 units in 13 states.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The FDA classification of Class II indicates potential for patient harm; however, no illnesses or injuries are mentioned in the source. The hazard (unauthorized modification affecting test accuracy) is theoretical rather than confirmed. Per the rubric, when no illnesses are reported and the hazard is theoretical, the maximum score is 3.
Plain-English summary
LumiraDx has recalled its SARS-CoV-2 Antibody Test Strip following discovery of modifications made outside the scope of the FDA-approved Emergency Use Authorization. This Class II recall affects the product's regulatory compliance status.
The affected product is the LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip, a diagnostic test used to detect antibodies to the SARS-CoV-2 virus. The recall involves 635 units distributed across seven specific lot numbers with expiration dates ranging from March 2022 to August 2022.
Distribution was limited to domestic markets in 13 states: Arkansas, California, Florida, Massachusetts, Maryland, North Carolina, New Jersey, Nevada, New York, Oklahoma, Tennessee, Texas, and Wisconsin.
Healthcare facilities and laboratories with affected test strips should refer to the official FDA Medical Device Recall database and contact LumiraDx for guidance on next steps.
The recalled product
- Product
- LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip
- Manufacturer
- LumiraDx
- Category
- Medical Device — Diagnostic Test
- Hazard
- unauthorized-modification
- diagnostic-inaccuracy
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 (7)
- No UDI codes. Catalog No. L017000109024. Lot No. 5000599 (Exp. 08-Mar-2022)
- 5000602 (Exp. 10-Mar-2022)
- 5000612 (Exp. 23-Mar-2022)
- 5000613 (Exp. 24-Mar-2022)
- 5000614 (Exp. 25-Mar-2022)
- 5000617 (Exp. 16-Apr-2022)
- and 5000676 (Exp. 25-Aug-2022).
Distribution
Distributed in 13 states:
- AR
- CA
- FL
- MA
- MD
- NC
- NJ
- NV
- NY
- OK
- TN
- TX
- WI
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