BEUDAMED
    FDA Recall Terminated

    G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes

    Recall: Z-1255-2019 · Initiated April 3, 2019

    Recall

    Recall Number
    Z-1255-2019
    Event Number
    82550
    Firm
    Randox Laboratories Ltd. 55 Diamond Road Crumlin (North) Ireland
    FEI Number
    1000361607
    Product Code
    JBL
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 3, 2019
    Terminated
    October 9, 2019

    Description

    G-6-PDH Normal Control (G-6-PDH CONTROL N), Catalogue Number PD2618 Product Usage: This product is intended for in vitro diagnostic use, in the quality control of Glucose-6-Phosphate Dehydrogenase in erythrocytes

    Reason

    The target values and ranges in these lots are incorrect.

    Action

    Randox sent an Urgent Medical Device Correction notification letters dated 4/2/19 to affected customers. The letter identified the affected product, problem and action to be taken: " Discontinue use of and quarantine any of the above devices immediately. " Discuss the contents of this notice with your Medical Director. " Review results generated with the affected batches in line with the clinical profile of the patient. " Inform all relevant staff members. If you have supplied or transferred any potentially affected product to another facility or organization, let that facility know of the recall immediately by providing a copy of this FSN and response form. " Complete and return the response form 12187-QA to [email protected] within five working days. For questions contact Randox Technical Services.

    Distribution

    The products were distributed to the following US states: IL, OH, NC, PA, WI, WV and Puerto Rico.

    Quantity

    10 kits