BEUDAMED
    FDA Enforcement Class II Terminated

    EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.

    Recall: Z-0697-2016 · Reported February 3, 2016

    Enforcement

    Recall Number
    Z-0697-2016
    Event ID
    72969
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Phadia Ab
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 3, 2016
    Initiation Date
    December 28, 2015
    Classification Date
    January 27, 2016
    Termination Date
    August 16, 2016
    Address
    Rapsgatan 7, Rapsgatan Plant, Uppsala, N/A, N/A, Sweden

    Description

    EliA SmDP Well, Article Number 14-5624-01 Product Usage: EliA SmDP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA SmDP uses the EliA IgG method on the instruments Phadia 100 and Phadia 250.

    Reason

    All equivocal and positive results (greater or equal 7 EliA U/ml) on EliA SmDP well lot 0018 may be incorrect and must be considered invalid. Patient samples in complaint investigations caused unspecific signals up to 22 U/ml on EliA SmDP well lot 0018. The nonspecific signals are not caused by anti-Sm antibodies, nor by streptavidin antibodies.

    Code Info

    Product number: 14-5624-01 Lot: 0018 Exp date: 11/30/2016

    Distribution

    US Nationwide in the states of NC, GA, NJ, NY, PA, TX, IL, MI, MT, NM, and OR.

    Quantity

    76