BEUDAMED
    FDA Recall 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 · Initiated January 11, 2021

    Recall

    Recall Number
    Z-1132-2021
    Event Number
    87259
    Firm
    LumiraDx
    FEI Number
    3012642695
    Product Code
    QKP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 11, 2021
    Posted
    February 17, 2021
    Terminated
    December 3, 2021
    Address
    221 Crescent St, Waltham, MA, 02453-3475

    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.

    Action

    On 01/28/2021, Lumiradx issued Urgent Medical Device Recall notices to customers via letter notifying customers the potential of false positive results in specified lots of LumiraDx SARS-CoV-2 Antigen (Ag) Test Strip. A false positive test result of a patient could result in potential exposure to unnecessary treatment or quarantine. (Updated 3/15/2021) On 2/26/2021, Lumiradx issued a second Urgent Medical Device Recall notice to customers via letter expanding the recall to include 3 additional lots. These lots are subject to recent feedback from a small number of customers regarding a small to moderate elevation in numbers of reported false positive patient test results.

    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)