BEUDAMED
    FDA Recall Open, Classified

    17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292

    Recall: Z-0258-2025 · Initiated September 13, 2024

    Recall

    Recall Number
    Z-0258-2025
    Event Number
    95429
    Firm
    DRG International, Inc.
    FEI Number
    2245285
    Product Code
    JLX
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    September 13, 2024
    Posted
    October 29, 2024
    Address
    841 Mountain Ave, Springfield, NJ, 07081-3437

    Description

    17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292

    Reason

    The High and Low Control acceptance ranges in the Certificate of Analysis (CofA) did not match the acceptance range information on the High and Low Control Component labels. Due to the defect, the device failed to provide results, which may result in a delay in obtaining test results and a remote chance of an adverse health risk.

    Action

    DRG issued Urgent Field Safety Notification on 9/17/24 via email. Letter states reason for recall, health risk and action to take: Please check your inventory for the respective lot and ensure that the proper acceptance ranges provided below are used to validate the assay. Immediately reply to email: [email protected] to confirm this notice and your compliance.

    Distribution

    AZ, CA, NH Foreign: Austria Belgium Georgia Germany Greece India Irak Italy Netherlands Poland Romania Russia Singapore Spain Tunesia Vietnam

    Quantity

    504 units