BEUDAMED
    FDA Recall Open, Classified

    Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1

    Recall: Z-0903-2023 · Initiated November 22, 2022

    Recall

    Recall Number
    Z-0903-2023
    Event Number
    91225
    Firm
    Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
    FEI Number
    1000361607
    Product Code
    JJY
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 22, 2022
    Posted
    January 5, 2023

    Description

    Liquid Assayed Specific Protein- In vitro diagnostic use, in the quality control of serum on clinical chemistry and immunoassay systems Catalog Number: PS2682 Control Level 1

    Reason

    Concentration of Rheumatoid Factor has decreased in Specific Protein Control Level 1-3 causing delay in reporting results due to Quality Controls running low outside range

    Action

    Randox Laboratories Ltd issued via email to the US Distributor Randox Laboratories-US, Ltd., Kearneysville, West Virginia on 11/22/22. The US Distributor contacted the customers by letter on 11/28/22. The Urgent Medical Device Correction letter states reason for recall, health risk and action to take: Discard previous IFUs and download the updated IFUs from randox.com Review results generated with the affected batches in line with the clinical profile of the patient. Discuss the contents of this notice with your Medical Director. Complete and return the response form 12187-QA to [email protected] within five working days. Transmission of Field Safety Notice: Send a copy of the FSN to all affected customers and to those who need to be aware within your organization.

    Distribution

    US Nationwide distribution in the states of CA, FL, OH,ME, MO, NC, NJ, PA, TN.

    Quantity

    146 units US