BEUDAMED
    FDA Recall Terminated

    UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls.

    Recall: Z-2687-2014 · Initiated August 21, 2014

    Recall

    Recall Number
    Z-2687-2014
    Event Number
    69107
    Firm
    Beckman Coulter Inc.
    FEI Number
    2050012
    Product Code
    JJE
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 21, 2014
    Posted
    September 23, 2014
    Terminated
    April 30, 2015
    Address
    250 S Kraemer Blvd, Brea, CA, 92821-6232

    Description

    UniCel 600/800 Access Immunoassay Systems are in vitro diagnostic devices used for the quantitative, semi-quantitative, or qualitative determination of various analytes concentrations found in human body fluids. The cables and kits are used in UniCel DxI 600, 800 instruments, and are distributed to Beckman and Non-Beckman Service Engineers for replacement of worn and/or damaged parts during field services calls.

    Reason

    Beckman Coulter is recalling the Sample Probe Cable because nonconforming sample probe cables may been installed on newly manufactured and/or recently serviced UniCel DxI 600 and 800 Access Immunoassay Systems, UniCel DxC 660i, 680i, and 860i, and UniCel DxC 880i Synchron Access Clinical Systems instruments. Use of a nonconforming sample probe cable can casuse a delay in reporting results, but wi

    Action

    A customer notification letter dated 8/21/14 was sent to all customers who purchased the Sample Probe Cable for use with the UniCel DxI Family of Immunoassay Systems. The letter informs the customers of the problems identified and the actions to be taken. Customer are instructed to complete and return the enclosed response form within 10 days. Customers are instructed to call (800) 854-3633 in US and Canada.

    Distribution

    Nationwide in US and worldwide: Canada, China, Colombia, Croatia, Czech Republic, France, Germany, India, Italy, Japan, Korea, Kuwait, Malaysia, Mexico, Philippines, Puerto Rico, Russia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, United States, Vietnam.

    Quantity

    236 units total (70 units in US)