BEUDAMED
    FDA Enforcement Class II Ongoing

    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 · Reported January 11, 2023

    Enforcement

    Recall Number
    Z-0903-2023
    Event ID
    91225
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Randox Laboratories Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 11, 2023
    Initiation Date
    November 22, 2022
    Classification Date
    January 5, 2023
    Address
    55 Diamond Road, N/A, Crumlin (North), N/A, N/A, Ireland

    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

    Code Info

    GTIN: 05055273204896 Lot Number/Exp. Date: 584LPC 28th Jun 23; 600LPC 28th Nov 23; 611LPC 28th Sep 24;

    Distribution

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

    Quantity

    146 units US