LumiraDx SARS-CoV-2 Antigen Test Strips Recalled for False Positives
LumiraDx is recalling specific lots of SARS-CoV-2 antigen test strips due to potential false positive results that could lead to unnecessary treatment or quarantine.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 recall is classified as High because it involves a risk-of-harm product (medical diagnostic) where the hazard is potential false positives leading to unnecessary treatment or quarantine, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
LumiraDx is recalling specific lots of the LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). The recall involves 3,274,272 test strips, with an additional 69,168 strips added to the count on March 15, 2021. The affected catalog number is L016000109048, and the specific lot numbers are 5000269 (GM2000238), 5000280 (GM2000232), 5000306 (GM2000261), 5000323 (GM2000354), 6000142 (GM2000296), and 6000100 (GM2000322).
The recall was initiated due to observations of potential false positive results in the specified lots. The use of these test strips may result in false positive patient test results, which could lead to potential exposure to unnecessary treatment or quarantine. The product is part of the LumiraDx Platform, a point-of-care system for professional use for in vitro diagnostic tests.
The affected test strips were distributed worldwide, including in the United States (California, Georgia, Pennsylvania, South Dakota) and in Austria, Germany, Ireland, Italy, Lebanon, Netherlands, Slovenia, Spain, and the United Kingdom. Healthcare professionals and facilities using these specific lots should stop using the affected test strips and contact LumiraDx for further instructions or replacement.
The recalled product
- Product
- LumiraDx SARS-CoV-2 Ag Test Strip Kit US EUA (48 Tests / EN). LumiraDx Severe Acute Respiratory Syndrome (SARS) CoV-2 Antigen (Ag) Test Strips, Catalog #:L016000109048. Part of the LumiraDx Platform, a point of care system for professional use for in vitro diagnostic tests.…
- Manufacturer
- LumiraDx
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 (5)
- Catalog #:L016000109048 Lot #: 5000269 (GM2000238)
- 5000280 (GM2000232)
- 5000306 (GM2000261) (Updated 3/15/2021) 5000323 (GM2000354)
- 6000142 (GM2000296)
- 6000100 (GM2000322)
Distribution
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