BEUDAMED
    FDA Recall Terminated

    CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories

    Recall: Z-1438-2017 · Initiated February 13, 2017

    Recall

    Recall Number
    Z-1438-2017
    Event Number
    76481
    Firm
    Abbott Laboratories
    FEI Number
    2919069
    Product Code
    GKZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 13, 2017
    Posted
    March 9, 2017
    Terminated
    March 6, 2018
    Address
    4551 Great America Pkwy, Santa Clara, CA, 95054-1208

    Description

    CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated hematology analyzer designed for in-vitro diagnostic use in clinical laboratories

    Reason

    The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage

    Action

    Product correction letters were sent to all affected customers on February 13, 2017 by traceable method. Letters provided information on the reason for the correction with all affected serial numbers listed. Abbott will be contacting each location to schedule replacement of the PCBA Pump Relay Board. Update: five additional serial numbers were added. Correction letters were sent to new consignees - 3 in Brazil and 2 in Mexico.

    Distribution

    US and Afghanistan, Brazil, Egypt, Tanzania, Hungary, Iraq, Kenya, Netherlands, Russia, Romania Vietnam, , United Kingdom, Saudi Arabia, Philippines, Lebanon, Mexico, Japan, Jordan, India, Indonesia, Turkey, UAE, Gaza & Jericho, Germany, Bulgaria, Chile, Argentina, Luxembourg.

    Quantity

    116