BEUDAMED
    FDA Recall Open, Classified

    Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.

    Recall: Z-1328-2024 · Initiated March 1, 2024

    Recall

    Recall Number
    Z-1328-2024
    Event Number
    94187
    Firm
    Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
    FEI Number
    1000361607
    Product Code
    JIX
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    March 1, 2024
    Posted
    March 20, 2024

    Description

    Liquid Protein Calibrators. C3 and Haptoglobin liquid protein calibrators used with Randox IgA, IgG, and IgM assays that require sample predilution.

    Reason

    The firm has realigned C3 and Haptoglobin in Liquid Protein Calibrators, IT2691, to reference material ERM-DA470k/IFCC.

    Action

    Consignees were sent a MEDICAL DEVICE CORRECTION NOTIFICATION dated 03/06/2024. The notification instructs consignees to review results generated with the affected batches in line with the clinical profile of the patient, discuss the contents of the provided recall notice with the facility's Medical Director, and complete and return the response form to [email protected] within five working days. The notice should be shared with all customers if product was further distributed and to those who need to be aware within consignee organizations. Consignees with questions should reach out to Randox Technical Services.

    Distribution

    Domestic: CA, FL, IL, ME, NJ, OH, & OR.

    Quantity

    1,764 units