BEUDAMED
    FDA Recall 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 · Initiated December 14, 2020

    Recall

    Recall Number
    Z-1107-2021
    Event Number
    87161
    Firm
    Phadia US Inc
    FEI Number
    3002807876
    Product Code
    LSW
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    December 14, 2020
    Posted
    February 11, 2021
    Terminated
    August 4, 2022
    Address
    4169 Commercial Ave, Portage, MI, 49002-9701

    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).

    Action

    Phadia US Inc. (Initial Importer/Distributor) issued notification to consignees via phone and FedEx overnight delivery Dec. 17-18 . Letter states reason for recall, health risk and action to take: Customers are asked to perform the following steps: 1.Scrap EliA dsDNA Well lot BFA3Y/0142 and order a replacement free of charge 2. Assess test results from EliA dsDNA Well lot BFA3Y/0142 and determine if retesting of samples is warranted in accordance with internal operating procedures. 3. Complete the Acknowledgement Form in the Medical Device Field Safety Notice and return the response to the contact person described. Any questions concerning this issue, contact Phadia US Technical Support at 1-800-346-4364, option #2.

    Distribution

    US Nationwide distribution.

    Quantity

    365 kits US