BEUDAMED
    FDA Recall Terminated

    Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.

    Recall: Z-2752-2020 · Initiated June 26, 2020

    Recall

    Recall Number
    Z-2752-2020
    Event Number
    86039
    Firm
    RANDOX LABORATORIES, LTD. 34 Diamond Rd Crumlin Colorado Antrim United Kingdom
    FEI Number
    3006697287
    Product Code
    CHI
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    June 26, 2020
    Posted
    August 4, 2020
    Terminated
    October 19, 2020

    Description

    Randox Lipase Assay: Lipase Colorimetric R1 Buffer - Product Usage: A Lipase test system is a device intended for the quantitative in vitro determination of Lipase in human serum and plasma.

    Reason

    Randox have confirmed imprecision of quality control and patient samples when using specific Randox Lipase buffer batches.

    Action

    Randox sent an urgent medical device correction notification dated June 22, 2020 explaining the current failure with select lots of Lipase Colorimetric products. The firm advised customers to scrap all effected product, keep proof of destruction, review replacements needs, review results of patients generated using affected batches and return the firm's response card.

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of Puerto Rico and WV.