BEUDAMED
    FDA Recall Terminated

    Assayed Bovine Multi-Sera Level 1, Model No. AL1027

    Recall: Z-2207-2019 · Initiated June 10, 2019

    Recall

    Recall Number
    Z-2207-2019
    Event Number
    83153
    Firm
    Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom
    FEI Number
    1000361607
    Product Code
    JJY
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    June 10, 2019
    Terminated
    June 16, 2020

    Description

    Assayed Bovine Multi-Sera Level 1, Model No. AL1027

    Reason

    The firm is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL.

    Action

    On June 7, 2019, the firm notified customers of the recall by issuing an Urgent Medical Device Correction letter. Customers were asked to take the following actions: * Inspect your stock and quarantine affected stock on hand to prevent further use. " Discard all value sheets and replace these with the value :sheets provided. " A review of previously generated patient results is not required as control failure is evident at the time of testing. " Discuss the contents of this notice with your Medical Director. " Complete and return the response form 12187-QA to [email protected] within five working days. *Send a copy of the FSN to all affected customers and to those who need to be aware within your organization. If you have any questions or concerns, please contact Rand ox Technical Services.

    Distribution

    Domestic distribution to Arizona, Oregon, Washington, and West Virginia. Foreign distribution to Australia, Belarus, Canada, France, Germany, Ireland, Kenya, Korea, Lithuania, New Zealand, Nigeria, Oman, Russia, Singapore, South Africa, Sweden, Switzerland, Turkey, and UK.

    Quantity

    4 kits (US)