BEUDAMED
    FDA Recall Terminated

    Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.

    Recall: Z-2150-2019 · Initiated June 11, 2019

    Recall

    Recall Number
    Z-2150-2019
    Event Number
    83155
    Firm
    Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom
    FEI Number
    1000361607
    Product Code
    JJY
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 11, 2019
    Terminated
    May 15, 2020

    Description

    Human Assayed Multi-Sera Level 2, Model NO. HN1530 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of diagnostic assays. The Human Assayed Multi-sera is for the control of accuracy.

    Reason

    The RX Series control target and range value for ALT (Tris buffer without P5P 37C), Bicarbonate and Gamma-GT has been incorrectly assigned in specific lots of the Human Assayed Multi-Sera Controls.

    Action

    On May 25, 2019, the firm notified its customers of the recall via Urgent Medical Device Correction letters. Customers were instructed to do the following: " Review your reagent inventory of these products. Remove all previous versions of the Value Sheets in use and replace with the revised version. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to t echnical.services@ randox.com within five working days. If you have any questions or concerns, please contact Randox Technical Services.

    Distribution

    US Nationwide Distribution - AZ CA CT FL GA IL KY LA MA MD MI MN MO NJ NY OH OK OR PA TX UT VA WA WI WV and PR. Worldwide foreign distribution.

    Quantity

    149 (US)