BEUDAMED
    FDA Enforcement Class II Terminated

    EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE). Material Number: 14-5500-01

    Recall: Z-1107-2021 · Reported February 17, 2021

    Enforcement

    Recall Number
    Z-1107-2021
    Event ID
    87161
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Phadia US Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 17, 2021
    Initiation Date
    December 14, 2020
    Classification Date
    February 11, 2021
    Termination Date
    August 4, 2022
    Address
    4169 Commercial Ave, N/A, Portage, MI, 49002-9701, United States

    Description

    EliA dsDNA Well - Product Usage: intended for the In-Vitro quantitative measurement of IgG antibodies directed to dsDNA in human serum and plasma as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE). Material Number: 14-5500-01

    Reason

    Decreased values for EliA ANA Positive Control when using the EliA dsDNA Well lot BFA37/0142 may potentially cause false positive results (increase in patient test results).

    Code Info

    Carrier Lot Number: BFA3Y; Kit Lot Number: 0142; (UDI): 07333066019406

    Distribution

    US Nationwide distribution.

    Quantity

    365 kits US