BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-1132-2021 · Reported February 24, 2021

    Enforcement

    Recall Number
    Z-1132-2021
    Event ID
    87259
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    LumiraDx
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 24, 2021
    Initiation Date
    January 11, 2021
    Classification Date
    February 17, 2021
    Termination Date
    December 3, 2021
    Address
    221 Crescent St, N/A, Waltham, MA, 02453-3475, United States

    Description

    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.

    Reason

    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.

    Code Info

    Catalog #:L016000109048 Lot #: 5000269 (GM2000238), 5000280 (GM2000232), 5000306 (GM2000261) (Updated 3/15/2021) 5000323 (GM2000354), 6000142 (GM2000296), 6000100 (GM2000322)

    Distribution

    Worldwide distribution. US states of CA, GA, PA, SD. (Updated 3/15/2021) Austria, Germany, Ireland, Italy, Lebanon, Netherlands, Slovenia, Spain, United Kingdom.

    Quantity

    3,274,272 strips (Updated 3/15/2021 added 69,168 strips)