FDAFebruary 3, 2021device
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 sympto...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Two lots of test strips failed QC testing using blank buffer due to false positives.
What to do
FDA enforcement status: Terminated
Brands named
lumiradx
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDASteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB2023-04-25
- FDALumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #: L016080109002 (EUA) The LumiraDx SARS-CoV-2 Quality Controls are intended for liquid quality control testing performed on the LumiraDx Instrument when used with the LumiraDx SARS-CoV-2 Ag Test Strip. The Quality Controls provi...2022-09-23
- FDALumiraDx SARS-CoV-2 Antibody (Ab) Test Strip2022-06-24
- FDALumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control2022-06-24
- FDALumiraDx 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. It comprises a portabl...2021-01-11
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