FDAJanuary 11, 2021device
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. It comprises a portabl...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Observations of potential false positive results in the specified lots. Use of these test strips may result in false positive patient test results and potential exposure to unnecessary treatment or quarantine.
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
- FDACoronavirus 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...2021-02-03
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