BEUDAMED
    FDA Recall Terminated

    Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. PHE reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Drug Calibrator 1, is intended for quantitative determination of Phenobarbital concentration in human serum or plasma.

    Recall: Z-1174-2012 · Initiated August 11, 2009

    Recall

    Recall Number
    Z-1174-2012
    Event Number
    60937
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    DKB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 11, 2009
    Posted
    March 6, 2012
    Terminated
    December 5, 2013
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. PHE reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Drug Calibrator 1, is intended for quantitative determination of Phenobarbital concentration in human serum or plasma.

    Reason

    The recall was initiated because Beckman Coulter has confirmed reports of variability in results with the lots of Phenobarbital (PHE) reagent and calibrator.

    Action

    Beckman Coulter sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated August 26, 2009 to all customers. The letter identifies the product, problem, and actions to be taken by the customers. Customers were instructed to share the recall information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. Customers were asked to complete and return a response form. Contact Beckman Coulter Customer Support Center (Hotline) at (800) 854-3633 for questions regarding this recall.

    Distribution

    Worldwide Distribution--USA (nationwide) and the country of Canada.

    Quantity

    31,559 units total (30,617 units in the US)