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    LumiraDx 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 provide users with assurance that the device is performing within specification

    FDA Recall
    Terminated ·LumiraDx·Product code QKP·September 23, 2022

    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 portable LumiraDx Instrument and a LumiraDx Test Strip for the required test.

    FDA Recall
    Terminated ·LumiraDx·Product code QKP·January 11, 2021

    LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control

    FDA Recall
    Terminated ·LumiraDx·Product code QKO·June 24, 2022

    LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip

    FDA Recall
    Terminated ·LumiraDx·Product code QKO·June 24, 2022

    SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB

    FDA Recall
    Open, Classified ·LumiraDx·Product code KXG·April 25, 2023

    AQURE REF 933-599 Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1 The AQURE system is intended to let you manage analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from connected devices at the point-of care or laboratory. It can send test results to the HIS/LIS. The system lets you send commands to selected devices. The system uses data related to the performance of devices, to tell users of issues to be managed. The AQURE system is intended for professional use.

    FDA Recall
    Open, Classified ·Radiometer Medical ApS Akandevej 21 Bronshoj Denmark·Product code OUG·March 8, 2023

    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 symptom onset.

    FDA Recall
    Terminated ·LumiraDx·Product code QKP·February 3, 2021